SepsisNCT07770347
Immunity in Critical Sepsis
A study testing Individualized anti-infective therapy, Individualized immunomodulatory therapy and Individualized organ function support therapy in people with Sepsis, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and remains the leading cause of death in critical care medicine worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Individualized anti-infective therapy, Individualized immunomodulatory therapy and Individualized organ function support therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ICU stay ≥ 24 hours
- Informed consent signed by the patient or their legal representative
Who cannot join
- ICU stay < 24 hours
- Refusal to provide informed consent
- Pregnancy or lactation
- Receiving palliative care or expected survival < 24 hours
- Previously enrolled in this study
- Severe immunodeficiency (HIV infection, or long-term use of corticosteroids/immunosuppressants)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicenter Registration Study on Sepsis in Critically Ill Patients
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and remains the leading cause of death in critical care medicine worldwide. According to the 2024 Global Burden of Disease data, there are 48.9 million new cases and 11 million deaths annually worldwide, with 11 million deaths accounting for 19.7% of all global deaths. In China, the incidence of sepsis continues to rise due to population aging, increased invasive procedures, overuse of antimicrobials, the prevalence of multidrug-resistant organisms, and a growing number of patients with chronic diseases. Regional studies indicate that the incidence of sepsis in Chinese ICUs ranges from 15% to 30%, with mortality rates as high as 40% to 60%-far exceeding those in developed countries. Among critically ill patients admitted to the ICU-such as those with severe trauma, major surgery, acute respiratory distress syndrome, severe pancreatitis, and advanced malignancies-hospital-acquired infections leading to secondary sepsis represent the most critical trigger for clinical deterioration, multiple organ dysfunction syndrome (MODS), and death. This creates a vicious cascade of "primary disease exacerbation → nosocomial infection → sepsis → MODS → death", resulting in skyrocketing costs, prolonged hospital stays, and heavy burdens on families and society.To address this challenge, this project aims to: (1) establish the largest and internationally leading multimodal dataset for severe sepsis in China, covering 19 tertiary ICUs nationwide over a 5-year period, with 5,300 critically ill patients including 800 sepsis cases, integrating clinical data, immunological indicators, biomarkers, microbiological data, imaging, longitudinal biospecimens, and long-term follow-up information into a standardized, shareable, and sustainable national sepsis database; (2) systematically elucidate the three core pathophysiological mechanisms of severe sepsis-identifying risk factors, pathogen profiles, antimicrobial resistance patterns, and early warning indicators; revealing the dynamic dysregulation patterns of cellular immunity, humoral immunity, and innate immunity to establish immunophenotyping standards; and clarifying the risk factors, mechanisms, and subtype characteristics of multiple organ injury; (3) foster interdisciplinary collaboration between medical and engineering sciences to develop a series of precision diagnostic and therapeutic tools, including AI-assisted early infection warning systems, rapid immunotyping assays, multi-organ injury prediction models, and individualized prognostic calculators for real-time, accurate, and non-invasive bedside assessment; (4) establish a comprehensive precision management system for sepsis, forming an integrated "prevention-early warning-diagnosis-immunotyping-stratified treatment-prognostic evaluation-rehabilitation" care pathway; (5) drive clinical translation to improve patient outcomes, aiming to reduce ICU sepsis incidence, mortality, and healthcare costs, while improving long-term quality of life, cognitive function, and psychological status of survivors and reducing readmission rates; and (6) build a national-level sepsis research platform and cultivate talent by establishing a nationwide collaborative research network, and training professionals with integrated clinical-research-translational competencies.
- Conditions
- Sepsis
- Being tested
- Individualized anti-infective therapy, Individualized immunomodulatory therapy, Individualized organ function support therapy, Standardized ICU nursing care strategies
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized anti-infective therapyOther
Antimicrobial agents (e.g., broad-spectrum or targeted antibiotics, antifungals) selected and adjusted by the attending physician based on suspected/confirmed infection source, culture and susceptibility results, and institutional antimicrobial stewardship protocols.
Individualized immunomodulatory therapyOther
Immunomodulatory agents (e.g., corticosteroids, intravenous immunoglobulin) administered at the discretion of the attending physician according to the patient's immune/inflammatory status and relevant clinical guidelines.
Individualized organ function support therapyOther
Organ support measures (e.g., mechanical ventilation, continuous renal replacement therapy, vasoactive agents) initiated and titrated by the treating team based on the patient's evolving organ function status.
Standardized ICU nursing care strategiesOther
Nursing care measures (e.g., protocolized sedation/analgesia management, glycemic control, pressure injury prevention, early mobilization) delivered according to unit-based standardized nursing protocols.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Treatment group | Experimental | Not described Receives: Other: Individualized anti-infective therapy; Other: Individualized immunomodulatory therapy; Other: Individualized organ function support therapy; Other: Standardized ICU nursing care strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual incidence of sepsis in ICU
Number of new sepsis cases (diagnosed by Sepsis-3 criteria) per 1,000 ICU admissions (or per 1,000 patient-days).
Measured: 90 days after enrollment.
Prevalence of sepsis in ICU
Percentage of ICU admissions meeting Sepsis-3 criteria for sepsis during the study period.
Measured: 90 days after enrollment
Distribution of infection site (lung/abdominal/bloodstream/urinary tract)
Percentage of patients with infection originating from the lung, abdomen, bloodstream, or urinary tract, respectively.
Measured: 90 days after enrollment
Distribution of infection type (community-acquired/hospital-acquired/secondary)
Percentage of patients with community-acquired, hospital-acquired, or secondary infection, respectively.
Measured: 90 days after enrollment
Pathogen distribution (Gram-negative/Gram-positive/fungal)
Percentage of microbiological isolates classified as Gram-negative bacteria, Gram-positive bacteria, or fungi.
Measured: 90 days after enrollment
Antimicrobial resistance rate (CRE/CRAB/MRSA)
Percentage of isolates identified as carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), or methicillin-resistant Staphylococcus aureus (MRSA).
Measured: 90 days after enrollment
ICU length of stay
Number of days from ICU admission to ICU discharge.
Measured: Through ICU discharge, up to 90 days
Duration of mechanical ventilation
Number of days on invasive mechanical ventilation.
Measured: Through 90 days
Duration of vasoactive agent use
Number of days on any vasoactive agent (e.g., norepinephrine, vasopressin, dobutamine, epinephrine).
Measured: Through 90 days
Duration of renal replacement therapy
Number of days receiving renal replacement therapy (continuous or intermittent).
Measured: Through 90 days
Daily ICU cost
Average direct cost of ICU care per patient per day, in Chinese Yuan (CNY).
Measured: Through ICU discharge, up to 90 days
Total hospitalization cost
Total direct cost of hospital care per patient, in Chinese Yuan (CNY), from hospital admission to discharge.
Measured: Through hospital discharge, up to 90 days
ICU mortality
Percentage of patients who die prior to ICU discharge.
Measured: Through ICU discharge, an average of 28 days
In-hospital mortality
Percentage of patients who die prior to hospital discharge.
Measured: Through hospital discharge, up to 90 days
28-day all-cause mortality
Percentage of patients who die from any cause within 28 days of enrollment.
Measured: 28 days after enrollment
90-day all-cause mortality
Percentage of patients who die from any cause within 90 days of enrollment.
Measured: 90 days after enrollment
Discriminative Performance of the Infection Risk-Prediction Model
Area under the receiver operating characteristic curve (AUC/C-statistic) of the multivariable model predicting infection occurrence, developed from patient, disease, and treatment-related candidate predictors using Cox regression, LASSO, and propensity score analysis.
Measured: 90 days after enrollment
Sensitivity and Specificity of the Infection Risk-Prediction Score
Sensitivity and specificity (%) of the infection risk-prediction score at its optimal cutoff value, determined by the Youden index.
Measured: 90 days after enrollment
Hand Hygiene Compliance Rate
Percentage of observed hand hygiene opportunities performed correctly, per WHO Five Moments guidance.
Measured: 90 days after enrollment
Catheter Care Bundle Compliance Rate
Percentage of eligible patient-days with full compliance to central line and urinary catheter care bundle elements.
Measured: 90 days after enrollment
Diagnostic Accuracy of Procalcitonin (PCT)
Area under the receiver operating characteristic curve (AUC) of serum Procalcitonin (PCT) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of C-Reactive Protein (CRP)
Area under the receiver operating characteristic curve (AUC) of serum C-Reactive Protein (CRP) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1)
Area under the receiver operating characteristic curve (AUC) of serum Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Presepsin
Area under the receiver operating characteristic curve (AUC) of serum Presepsin concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Soluble Urokinase Plasminogen Activator Receptor (suPAR)
Area under the receiver operating characteristic curve (AUC) of serum Soluble Urokinase Plasminogen Activator Receptor (suPAR) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Interleukin-6 (IL-6)
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-6 (IL-6) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Interleukin-8 (IL-8)
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-8 (IL-8) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
Diagnostic Accuracy of Pro-Adrenomedullin (Pro-ADM)
Area under the receiver operating characteristic curve (AUC) of serum Pro-Adrenomedullin (Pro-ADM) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Measured: At enrollment (baseline), and at 72 hours after enrollment
AUC of Combined Multi-Parameter Early-Warning Model
Area under the receiver operating characteristic curve of a composite model integrating vital signs (temperature, heart rate, respiratory rate, blood pressure, SpO2), laboratory values, and the biomarkers listed above for early warning of infection.
Measured: From 24 hours before to 72 hours after infection onset
Diagnostic Accuracy of AI-Based Automated Warning System
Accuracy (%) of a machine-learning-based (random forest, XGBoost, deep learning) automated warning system using electronic medical record data to predict infection onset.
Measured: From 24 hours before to 72 hours after infection onset
Lead Time of AI-Based Warning System
Time interval, in hours, between the AI system alert and the subsequent clinical diagnosis of infection.
Measured: Up to 24 hours before clinical diagnosis
Time to First Effective Antibiotic Administration
Time, in hours, from infection recognition to administration of the first in vitro active antibiotic.
Measured: Within 6 hours of infection onset
Rate of Appropriate Empirical Antibiotic Therapy
Percentage of patients receiving empirical antibiotic therapy subsequently confirmed to be active against the identified pathogen(s).
Measured: 90 days after enrollment
Rate of Antibiotic Coverage of Resistant Organisms
Percentage of patients with identified multidrug-resistant organisms whose empirical antibiotic regimen provided adequate in vitro coverage.
Measured: 90 days after enrollment
Antibiotic De-escalation Rate
Percentage of patients whose antibiotic regimen was narrowed (de-escalated) based on culture and susceptibility results.
Measured: 90 days after enrollment
Duration of Antibiotic Therapy
Number of days of antibiotic treatment administered for the index infection.
Measured: 90 days after enrollment
Time to Source Control
Time, in hours, from infection recognition to definitive source-control intervention (drainage, debridement, catheter removal, or surgery).
Measured: 90 days after enrollment
Compliance Rate with SSC Bundle Elements
Percentage of eligible patients/bundle elements for which Surviving Sepsis Campaign bundle elements were completed within the recommended time window.
Measured: 90 days after enrollment
Total hospital length of stay
Number of days from hospital admission to hospital discharge.
Measured: Through hospital discharge, up to 90 days
Secondary outcomes (76)
CD3+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD3+ T lymphocytes, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD4+ T lymphocytes, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD8+ T Lymphocyte Count/Percentage
Absolute count (cells/μL) and/or percentage of CD8+ T lymphocytes, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+/CD8+ Ratio
Ratio of CD4+ to CD8+ T lymphocyte counts, calculated from flow cytometry measurements
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Regulatory T Cell (Treg) Percentage
Percentage of CD4+CD25+FoxP3+ regulatory T cells among total CD4+ T cells, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Th1/Th2 Ratio
Ratio of Th1 to Th2 helper T cell subsets, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte HLA-DR (mHLA-DR) Expression
Monocyte human leukocyte antigen-DR expression, measured by flow cytometry and reported as mean fluorescence intensity or percentage of HLA-DR-positive monocytes.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Natural Killer (NK) Cell Count/Percentage
Absolute count (cells/μL) and/or percentage of NK cells, measured by flow cytometry.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Absolute Lymphocyte Count
Total lymphocyte count, in cells/μL, measured by complete blood count with differential.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Lymphocyte Apoptosis Rate
Percentage of lymphocytes undergoing apoptosis, measured by flow cytometry (e.g., Annexin V/propidium iodide staining).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte Phagocytic Index
Percentage of monocytes demonstrating phagocytic activity, measured by flow cytometry-based phagocytosis assay, reported as percentage of phagocytic monocytes (%).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Ferritin Concentration
Serum ferritin concentration, in ng/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgG Concentration
Serum concentration of IgG, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgA Concentration
Serum concentration of IgA, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgM Concentration
Serum concentration of IgM, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C3 Concentration
Serum concentration of C3, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C4 Concentration
Serum concentration of C4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C5a Concentration
Serum concentration of C5a, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-1β Concentration
Serum concentration of IL-1β, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-2 Concentration
Serum concentration of IL-2, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-4 Concentration
Serum concentration of IL-4, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-6 Concentration
Serum concentration of IL-6, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-8 Concentration
Serum concentration of IL-8, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-10 Concentration
Serum concentration of IL-10, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum TNF-α Concentration
Serum concentration of TNF-α, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IFN-γ Concentration
Serum concentration of IFN-γ, measured by immunoassay (e.g., ELISA or multiplex bead-based assay).
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Pro-/Anti-Inflammatory Cytokine Ratio
Ratio of serum IL-6 to IL-10 concentration, calculated as a composite index of pro- versus anti-inflammatory balance.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Incidence of Immunoparalysis
Percentage of patients with monocyte HLA-DR (mHLA-DR) expression below 8,000 antibodies/cell (measured by quantitative flow cytometry, QuantiBRITE method), indicating immunoparalysis.
Measured: Through 5 days after enrollment
Duration of Immunoparalysis
Number of days during which mHLA-DR expression remains below the pre-specified immunoparalysis threshold.
Measured: Through day 5 after enrollment
Time to Onset of Immunoparalysis
Time, in hours, from infection recognition to the first mHLA-DR measurement below the pre-specified immunoparalysis threshold.
Measured: Within 24 hours after infection onset
Proportion of Patients with Hyperinflammatory Immune Phenotype
Percentage of patients classified as hyperinflammatory phenotype (high IL-6/TNF-α/ferritin, low IL-10, normal CD4+/mHLA-DR) by unsupervised clustering (K-means/latent class analysis/PCA) of the immune parameters listed above.
Measured: Within 5 days after enrollment
Proportion of Patients with Immunosuppressive Immune Phenotype
Percentage of patients classified as immunosuppressive phenotype (normal IL-6/TNF-α/ferritin, high IL-10, low CD4+, high Treg, low mHLA-DR) by the same clustering method.
Measured: Within 5 days after enrollment
Proportion of Patients with Mixed Immune Phenotype
Percentage of patients classified as mixed phenotype (concurrently elevated pro- and anti-inflammatory markers) by the same clustering method.
Measured: Within 5 days after enrollment
Sensitivity and Specificity of Bedside Rapid Immunophenotyping Test
Sensitivity and specificity (%) of a bedside rapid test/scoring tool for immune phenotype classification, benchmarked against the reference clustering-based classification.
Measured: Within 5 days after enrollment
Time to Complete Bedside Immunophenotyping Test
Time, in minutes, required to obtain a result from the bedside rapid immunophenotyping test.
Measured: Within 5 days after enrollment
Plasma Angiopoietin-2 (Ang-2) Concentration
Plasma Ang-2 concentration, in pg/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Soluble VCAM-1 Concentration
Serum/plasma soluble vascular cell adhesion molecule-1 concentration, in ng/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
VEGF Concentration
Vascular endothelial growth factor concentration, in pg/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Endothelin-1 Concentration
Plasma endothelin-1 concentration, in pg/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
DPP3 Concentration
Plasma dipeptidyl peptidase 3 concentration, in ng/mL, measured by immunoassay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Fibrinogen Concentration
Plasma fibrinogen concentration, in g/L, measured by standard coagulation assay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Platelet Count
Platelet count, in ×10⁹/L, measured by complete blood count.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Thrombin Time
Thrombin time, in seconds, measured by standard coagulation assay.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of D-dimer
Plasma D-dimer concentration measured at each specified timepoint, reported in μg/mL (or ng/mL FEU).
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Discriminative Performance of Multi-Organ Injury Risk-Prediction Model
Area under the receiver operating characteristic curve (AUC/C-statistic) of the multivariable model predicting multi-organ injury, developed from infection, immune, endothelial, coagulation, and patient/treatment-related candidate predictors using Cox regression, LASSO, and machine learning methods.
Measured: 90 days after enrollment
Sensitivity and Specificity of Multi-Organ Injury Risk Score
Sensitivity and specificity (%) of the multi-organ injury risk score at its optimal cutoff value.
Measured: 90 days after enrollment
Composite Multi-Organ Dysfunction Score (MODS-score)
Multi-organ dysfunction assessed by the Marshall Multiple Organ Dysfunction Score (MODS), which evaluates six organ systems (respiratory, renal, hepatic, cardiovascular, hematologic, and neurologic), each scored 0-4, for a total score ranging from 0 (no dysfunction) to 24 (maximum dysfunction). Higher scores indicate more severe multi-organ dysfunction.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, at 5 days after diagnosis and 90 days after diagnosis
Serum Creatinine Concentration
Serum creatinine concentration, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting renal function.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Total Bilirubin Concentration
Serum total bilirubin concentration, in μmol/L (or mg/dL), measured by standard laboratory assay, reflecting hepatic function.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Troponin Concentration
Serum concentration of high-sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI), measured by standard immunoassay, reported in ng/L (or ng/mL), reflecting myocardial injury.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Lactate Concentration
Serum lactate concentration, in mmol/L, measured by standard laboratory assay.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Syndecan-1 Concentration
Serum syndecan-1 concentration, in ng/mL, measured by immunoassay, reflecting glycocalyx/endothelial injury.
Measured: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Proportion of Patients per Organ-Injury Subtype
Percentage of patients classified as lung-predominant, kidney-predominant, heart-predominant, coagulation-predominant, or mixed subtype, based on the pattern, mechanism, and severity of organ injury.
Measured: Within 5 days after enrollment
Rate of Multi-Organ Injury Progression
Percentage of patients demonstrating worsening of organ-specific SOFA sub-score between baseline and 72 hours.
Measured: From baseline (at infection diagnosis) to 72 hours after diagnosis
Rate of Multi-Organ Injury Reversibility
Percentage of patients demonstrating recovery of organ-specific SOFA sub-score between 72 hours and day 5.
Measured: From 72 hours after diagnosis to 5 days after diagnosis
Compliance Rate with Lung-Protective Ventilation Strategy
Percentage of mechanically ventilated patients receiving tidal volume ≤8 mL/kg predicted body weight.
Measured: 90 days after enrollment
Time from AKI Diagnosis to RRT Initiation
Time, in hours, from acute kidney injury diagnosis to initiation of renal replacement therapy.
Measured: 90 days after enrollment
Lactate Clearance Rate
Percentage change in serum lactate concentration from baseline to 72 hours after diagnosis, calculated as (baseline lactate - 72-hour lactate) / baseline lactate × 100%.
Measured: From baseline (at infection diagnosis) to 72 hours after diagnosis
Discriminative Performance of Prognostic Model for 28-Day Mortality
Area under the receiver operating characteristic curve (AUC/C-statistic) of a prognostic model integrating infection, immune, and organ-injury indicators to predict 28-day all-cause mortality.
Measured: 28 days after enrollment
Discriminative Performance of Prognostic Model for 90-Day Mortality
Area under the receiver operating characteristic curve (AUC/C-statistic) of the same prognostic model to predict 90-day all-cause mortality.
Measured: 90 days after enrollment
1-Year All-Cause Survival Rate
Percentage of enrolled patients alive at 1 year after enrollment.
Measured: 1 year after enrollment
Hospital Readmission Rate
Percentage of patients readmitted to the hospital for any cause within 1 year after enrollment.
Measured: 1 year after enrollment
Cognitive Function (MoCA)
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA), scored 0-30 (higher scores indicate better cognitive function).
Measured: 1 year after enrollment
Cognitive Function (TICS)
Cognitive function assessed by the Telephone Interview for Cognitive Status (TICS), scored 0-41, with higher scores indicating better cognitive function.
Measured: 1 year after enrollment
Anxiety Symptoms (HADS-Anxiety subscale)
Anxiety symptoms assessed by the Hospital Anxiety and Depression Scale, Anxiety subscale (HADS-A), scored 0-21 (higher scores indicate more severe anxiety).
Measured: 1 year after enrollment
Depressive Symptoms (HADS-Depression subscale)
Depressive symptoms assessed by the Hospital Anxiety and Depression Scale, Depression subscale (HADS-D), scored 0-21 (higher scores indicate more severe depression).
Measured: 1 year after enrollment
Post-Traumatic Stress Symptoms
Post-traumatic stress symptoms assessed by the PTSD Checklist for DSM-5 (PCL-5), a 20-item self-report measure scored 0-80, with higher scores indicating more severe post-traumatic stress symptoms.
Measured: 1 year after enrollment
Functional Disability (mRS)
Functional disability assessed by the modified Rankin Scale (mRS), scored 0-6 (higher scores indicate greater disability).
Measured: 1 year after enrollment
Activities of Daily Living (Barthel Index)
Activities of daily living assessed by the Barthel Index, scored 0-100 (higher scores indicate greater independence).
Measured: 1 year after enrollment
Muscle Function
Muscle function assessed by the Medical Research Council (MRC) sum score, which evaluates strength in six muscle groups bilaterally (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors), each scored 0-5, for a total score ranging from 0 (complete paralysis) to 60 (normal strength). Lower scores indicate greater muscle weakness; an MRC sum score <48 is commonly used to define ICU-acquired weakness.
Measured: 1 year after enrollment
Health-Related Quality of Life (EQ-5D-5L Utility Index)
Health-related quality of life assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system, reported as a utility index value derived using the Chinese value set. The utility index ranges from -0.391 (worst health state) to 1.0 (full health), with higher scores indicating better health-related quality of life. A score of 0 represents a health state equivalent to death, and negative scores represent health states considered worse than death.
Measured: 1 year after enrollment
Health-Related Quality of Life (EQ-VAS)
Health-related quality of life assessed by the EQ-5D-5L Visual Analogue Scale, scored 0-100 (higher scores indicate better self-rated health).
Measured: 1 year after enrollment
Concentration of Plasmin-Antiplasmin Complex (PAP)
Plasma PAP complex concentration measured at each specified timepoint, reported in ng/mL.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Tissue Plasminogen Activator (tPA)
Plasma tPA concentration measured at each specified timepoint, reported in ng/mL
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Plasminogen Activator Inhibitor-1 (PAI-1)
Plasma PAI-1 concentration measured at each specified timepoint, reported in ng/mL
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Concentration of Fibrin/Fibrinogen Degradation Products (FDP)
Plasma FDP concentration measured at each specified timepoint, reported in μg/mL.
Measured: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Jun 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Hebei Province, Tianjin First Central Hospital, Second Hospital of Shanxi Medical University, Beijing Obstetrics and Gynecology Hospital, Affiliated Hospital of Hebei University, Hebei Provincial Hospital of Traditional Chinese Medicine, Hangzhou Hospital of Traditional Chinese Medicine, Baoding First Central Hospital, Beijing Shuyi Hospital, Cangzhou Central Hospital, Hengshui People's Hospital, Sixth Hospital of Shanxi Medical University, Changzhi People's Hospital, Jincheng People's Hospital, Xinxiang Central Hospital, Luohe Central Hospital, Inner Mongolia Baogang Hospital, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770347
- Sponsor's protocol ID
- CriticalSepsisImmunity
- Status last verified
- Jun 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registration Study on Sepsis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07770347
- Acronym / sponsor ID
- CriticalSepsisImmunity
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- The People's Hospital of Hebei Province, Tianjin First Central Hospital, Second Hospital of Shanxi Medical University, Beijing Obstetrics and Gynecology Hospital, Affiliated Hospital of Hebei University, Hebei Provincial Hospital of Traditional Chinese Medicine, Hangzhou Hospital of Traditional Chinese Medicine, Baoding First Central Hospital, Beijing Shuyi Hospital, Cangzhou Central Hospital, Hengshui People's Hospital, Sixth Hospital of Shanxi Medical University, Changzhi People's Hospital, Jincheng People's Hospital, Xinxiang Central Hospital, Luohe Central Hospital, Inner Mongolia Baogang Hospital, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and remains the leading cause of death in critical care medicine worldwide. According to the 2024 Global Burden of Disease data, there are 48.9 million new cases and 11 million deaths annually worldwide, with 11 million deaths accounting for 19.7% of all global deaths. In China, the incidence of sepsis continues to rise due to population aging, increased invasive procedures, overuse of antimicrobials, the prevalence of multidrug-resistant organisms, and a growing number of patients with chronic diseases. Regional studies indicate that the incidence of sepsis in Chinese ICUs ranges from 15% to 30%, with mortality rates as high as 40% to 60%-far exceeding those in developed countries. Among critically ill patients admitted to the ICU-such as those with severe trauma, major surgery, acute respiratory distress syndrome, severe pancreatitis, and advanced malignancies-hospital-acquired infections leading to secondary sepsis represent the most critical trigger for clinical deterioration, multiple organ dysfunction syndrome (MODS), and death. This creates a vicious cascade of "primary disease exacerbation → nosocomial infection → sepsis → MODS → death", resulting in skyrocketing costs, prolonged hospital stays, and heavy burdens on families and society.To address this challenge, this project aims to: (1) establish the largest and internationally leading multimodal dataset for severe sepsis in China, covering 19 tertiary ICUs nationwide over a 5-year period, with 5,300 critically ill patients including 800 sepsis cases, integrating clinical data, immunological indicators, biomarkers, microbiological data, imaging, longitudinal biospecimens, and long-term follow-up information into a standardized, shareable, and sustainable national sepsis database; (2) systematically elucidate the three core pathophysiological mechanisms of severe sepsis-identifying risk factors, pathogen profiles, antimicrobial resistance patterns, and early warning indicators; revealing the dynamic dysregulation patterns of cellular immunity, humoral immunity, and innate immunity to establish immunophenotyping standards; and clarifying the risk factors, mechanisms, and subtype characteristics of multiple organ injury; (3) foster interdisciplinary collaboration between medical and engineering sciences to develop a series of precision diagnostic and therapeutic tools, including AI-assisted early infection warning systems, rapid immunotyping assays, multi-organ injury prediction models, and individualized prognostic calculators for real-time, accurate, and non-invasive bedside assessment; (4) establish a comprehensive precision management system for sepsis, forming an integrated "prevention-early warning-diagnosis-immunotyping-stratified treatment-prognostic evaluation-rehabilitation" care pathway; (5) drive clinical translation to improve patient outcomes, aiming to reduce ICU sepsis incidence, mortality, and healthcare costs, while improving long-term quality of life, cognitive function, and psychological status of survivors and reducing readmission rates; and (6) build a national-level sepsis research platform and cultivate talent by establishing a nationwide collaborative research network, and training professionals with integrated clinical-research-translational competencies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Treatment group | Experimental | Other: Individualized anti-infective therapy, Other: Individualized immunomodulatory therapy, Other: Individualized organ function support therapy, Other: Standardized ICU nursing care strategies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- ICU stay ≥ 24 hours
- Informed consent signed by the patient or their legal representative
Key exclusion criteria (6 listed)
- ICU stay < 24 hours
- Refusal to provide informed consent
- Pregnancy or lactation
- Receiving palliative care or expected survival < 24 hours
- Previously enrolled in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized anti-infective therapyAntimicrobial agents (e.g., broad-spectrum or targeted antibiotics, antifungals) selected and adjusted by the attending physician based on suspected/confirmed infection source, culture and susceptibility results, and institutional antimicrobial stewardship protocols. | Other | Treatment group |
| Individualized immunomodulatory therapyImmunomodulatory agents (e.g., corticosteroids, intravenous immunoglobulin) administered at the discretion of the attending physician according to the patient's immune/inflammatory status and relevant clinical guidelines. | Other | Treatment group |
| Individualized organ function support therapyOrgan support measures (e.g., mechanical ventilation, continuous renal replacement therapy, vasoactive agents) initiated and titrated by the treating team based on the patient's evolving organ function status. | Other | Treatment group |
| Standardized ICU nursing care strategiesNursing care measures (e.g., protocolized sedation/analgesia management, glycemic control, pressure injury prevention, early mobilization) delivered according to unit-based standardized nursing protocols. | Other | Treatment group |
Primary outcome
Annual incidence of sepsis in ICU
Time frame: 90 days after enrollment.
Number of new sepsis cases (diagnosed by Sepsis-3 criteria) per 1,000 ICU admissions (or per 1,000 patient-days).
Prevalence of sepsis in ICU
Time frame: 90 days after enrollment
Percentage of ICU admissions meeting Sepsis-3 criteria for sepsis during the study period.
Distribution of infection site (lung/abdominal/bloodstream/urinary tract)
Time frame: 90 days after enrollment
Percentage of patients with infection originating from the lung, abdomen, bloodstream, or urinary tract, respectively.
Distribution of infection type (community-acquired/hospital-acquired/secondary)
Time frame: 90 days after enrollment
Percentage of patients with community-acquired, hospital-acquired, or secondary infection, respectively.
Pathogen distribution (Gram-negative/Gram-positive/fungal)
Time frame: 90 days after enrollment
Percentage of microbiological isolates classified as Gram-negative bacteria, Gram-positive bacteria, or fungi.
Antimicrobial resistance rate (CRE/CRAB/MRSA)
Time frame: 90 days after enrollment
Percentage of isolates identified as carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), or methicillin-resistant Staphylococcus aureus (MRSA).
ICU length of stay
Time frame: Through ICU discharge, up to 90 days
Number of days from ICU admission to ICU discharge.
Duration of mechanical ventilation
Time frame: Through 90 days
Number of days on invasive mechanical ventilation.
Duration of vasoactive agent use
Time frame: Through 90 days
Number of days on any vasoactive agent (e.g., norepinephrine, vasopressin, dobutamine, epinephrine).
Duration of renal replacement therapy
Time frame: Through 90 days
Number of days receiving renal replacement therapy (continuous or intermittent).
Daily ICU cost
Time frame: Through ICU discharge, up to 90 days
Average direct cost of ICU care per patient per day, in Chinese Yuan (CNY).
Total hospitalization cost
Time frame: Through hospital discharge, up to 90 days
Total direct cost of hospital care per patient, in Chinese Yuan (CNY), from hospital admission to discharge.
ICU mortality
Time frame: Through ICU discharge, an average of 28 days
Percentage of patients who die prior to ICU discharge.
In-hospital mortality
Time frame: Through hospital discharge, up to 90 days
Percentage of patients who die prior to hospital discharge.
28-day all-cause mortality
Time frame: 28 days after enrollment
Percentage of patients who die from any cause within 28 days of enrollment.
90-day all-cause mortality
Time frame: 90 days after enrollment
Percentage of patients who die from any cause within 90 days of enrollment.
Discriminative Performance of the Infection Risk-Prediction Model
Time frame: 90 days after enrollment
Area under the receiver operating characteristic curve (AUC/C-statistic) of the multivariable model predicting infection occurrence, developed from patient, disease, and treatment-related candidate predictors using Cox regression, LASSO, and propensity score analysis.
Sensitivity and Specificity of the Infection Risk-Prediction Score
Time frame: 90 days after enrollment
Sensitivity and specificity (%) of the infection risk-prediction score at its optimal cutoff value, determined by the Youden index.
Hand Hygiene Compliance Rate
Time frame: 90 days after enrollment
Percentage of observed hand hygiene opportunities performed correctly, per WHO Five Moments guidance.
Catheter Care Bundle Compliance Rate
Time frame: 90 days after enrollment
Percentage of eligible patient-days with full compliance to central line and urinary catheter care bundle elements.
Diagnostic Accuracy of Procalcitonin (PCT)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Procalcitonin (PCT) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of C-Reactive Protein (CRP)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum C-Reactive Protein (CRP) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Presepsin
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Presepsin concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Soluble Urokinase Plasminogen Activator Receptor (suPAR)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Soluble Urokinase Plasminogen Activator Receptor (suPAR) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Interleukin-6 (IL-6)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-6 (IL-6) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Interleukin-8 (IL-8)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Interleukin-8 (IL-8) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
Diagnostic Accuracy of Pro-Adrenomedullin (Pro-ADM)
Time frame: At enrollment (baseline), and at 72 hours after enrollment
Area under the receiver operating characteristic curve (AUC) of serum Pro-Adrenomedullin (Pro-ADM) concentration for differentiating infection from non-infection and sepsis from non-sepsis, with corresponding sensitivity, specificity, and optimal cutoff value.
AUC of Combined Multi-Parameter Early-Warning Model
Time frame: From 24 hours before to 72 hours after infection onset
Area under the receiver operating characteristic curve of a composite model integrating vital signs (temperature, heart rate, respiratory rate, blood pressure, SpO2), laboratory values, and the biomarkers listed above for early warning of infection.
Diagnostic Accuracy of AI-Based Automated Warning System
Time frame: From 24 hours before to 72 hours after infection onset
Accuracy (%) of a machine-learning-based (random forest, XGBoost, deep learning) automated warning system using electronic medical record data to predict infection onset.
Lead Time of AI-Based Warning System
Time frame: Up to 24 hours before clinical diagnosis
Time interval, in hours, between the AI system alert and the subsequent clinical diagnosis of infection.
Time to First Effective Antibiotic Administration
Time frame: Within 6 hours of infection onset
Time, in hours, from infection recognition to administration of the first in vitro active antibiotic.
Rate of Appropriate Empirical Antibiotic Therapy
Time frame: 90 days after enrollment
Percentage of patients receiving empirical antibiotic therapy subsequently confirmed to be active against the identified pathogen(s).
Rate of Antibiotic Coverage of Resistant Organisms
Time frame: 90 days after enrollment
Percentage of patients with identified multidrug-resistant organisms whose empirical antibiotic regimen provided adequate in vitro coverage.
Antibiotic De-escalation Rate
Time frame: 90 days after enrollment
Percentage of patients whose antibiotic regimen was narrowed (de-escalated) based on culture and susceptibility results.
Duration of Antibiotic Therapy
Time frame: 90 days after enrollment
Number of days of antibiotic treatment administered for the index infection.
Time to Source Control
Time frame: 90 days after enrollment
Time, in hours, from infection recognition to definitive source-control intervention (drainage, debridement, catheter removal, or surgery).
Compliance Rate with SSC Bundle Elements
Time frame: 90 days after enrollment
Percentage of eligible patients/bundle elements for which Surviving Sepsis Campaign bundle elements were completed within the recommended time window.
Total hospital length of stay
Time frame: Through hospital discharge, up to 90 days
Number of days from hospital admission to hospital discharge.
76 secondary outcomes
CD3+ T Lymphocyte Count/Percentage
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+ T Lymphocyte Count/Percentage
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD8+ T Lymphocyte Count/Percentage
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
CD4+/CD8+ Ratio
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Regulatory T Cell (Treg) Percentage
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Th1/Th2 Ratio
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte HLA-DR (mHLA-DR) Expression
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Natural Killer (NK) Cell Count/Percentage
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Absolute Lymphocyte Count
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Lymphocyte Apoptosis Rate
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Monocyte Phagocytic Index
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum Ferritin Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgG Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgA Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IgM Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C3 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C4 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Complement C5a Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-1β Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-2 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-4 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-6 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-8 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IL-10 Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum TNF-α Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Serum IFN-γ Concentration
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Pro-/Anti-Inflammatory Cytokine Ratio
Time frame: At ICU admission (baseline), at the time of infection diagnosis, at 72 hours after diagnosis, and at 5 days after diagnosis
Incidence of Immunoparalysis
Time frame: Through 5 days after enrollment
Duration of Immunoparalysis
Time frame: Through day 5 after enrollment
Time to Onset of Immunoparalysis
Time frame: Within 24 hours after infection onset
Proportion of Patients with Hyperinflammatory Immune Phenotype
Time frame: Within 5 days after enrollment
Proportion of Patients with Immunosuppressive Immune Phenotype
Time frame: Within 5 days after enrollment
Proportion of Patients with Mixed Immune Phenotype
Time frame: Within 5 days after enrollment
Sensitivity and Specificity of Bedside Rapid Immunophenotyping Test
Time frame: Within 5 days after enrollment
Time to Complete Bedside Immunophenotyping Test
Time frame: Within 5 days after enrollment
Plasma Angiopoietin-2 (Ang-2) Concentration
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Soluble VCAM-1 Concentration
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
VEGF Concentration
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Endothelin-1 Concentration
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
DPP3 Concentration
Time frame: At ICU admission (baseline), at the time of sepsis diagnosis, and at 72 hours after sepsis diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized anti-infective therapy, Individualized immunomodulatory therapy and Individualized organ function support therapy in people with Sepsis, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual incidence of sepsis in ICU (time frame: 90 days after enrollment.). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.