SepsisEPoSNCT03996759
Early Prediction of Sepsis by Using Metabolomics
An observational study of Sepsis, run by Xi Peng at 1 site in China.
Trial summary
Sepsis is a serious medical condition associated with a high incidence and mortality rate. It is the leading cause of death in ICU worldwide. Nowadays sepsis was redefined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Laboratory diagnostic medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU.
Who may be able to join
- male and female aged 18-80 years old
- confirmed infection (e.g. pulmonary, urinary, blood, abdominal, and pelvic infection)
- APACHE II ≥15 and SOFA < 2 within 24 hours of admission
- ICU length of stay ≥ 3 days
Who cannot join
- pregnant and/or lactating women
- previously suffered from immune diseases and/or long-term use of glucocorticoids
- chronic renal failure or hemodialysis
- patients who expressly refuse consent
- patient who is undergoing other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Xi Peng, PhD, MD, 86-23-68754435, pxlrmm@163.com
About this study
Official title: Early Prediction of Sepsis by Metabolomic Pofiling in Critically Ill Patients
Sepsis is a serious medical condition associated with a high incidence and mortality rate. It is the leading cause of death in ICU worldwide. Nowadays sepsis was redefined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Despite the progress made in the pathogenesis of sepsis and advances achieved in medical interventions, the management of sepsis remains a challenge for clinicians. The core problem that precludes the promotion in the management of sepsis is the lack of early and precise prediction. The metabolic profiles will be significantly changed when body suffers from sepsis even though the organ function remains normal, thus making it possible to predict sepsis in the early stage through the detection of the metabolites.
Read the detailed description
In the past the studies on the prediction and prognosis of sepsis were focused on the levels of protein and gene, and few researches have been done in the field of metabolomics. Actually the changes in the functioning of biological systems can be reflected not only by the specifically expressed protein but also by the metabolism. The metabolic characteristic of biological fluids will be significantly changed when body suffers from pathological or physiological stimulation, and these changes can reveal the disease state or severity while the organ function remains normal due to the compensatory action. Therefore it is possible to predict the occurrence, development and prognosis of sepsis in the early stage through the detection of the concentrations or ratios of these metabolites. The traditional methods are difficult to adapt to the detection of such complicated changes in metabolic profiles when sepsis occurs, thus there is a huge demand of novel means for the metabolic profiling in the inflammatory reaction. By now there have been several researches involved in the metabolic profiling in severe wound, but few have been done in the field of critical care medicine. The metabolic profiles in sepsis patients have remained unclear so far. Therefore it is of great significance to develop a metabolic profiling approach for the measurement and interpretation of the metabolites from the biological samples of sepsis patients and to establish a mode for the metabolomics-based early prediction of sepsis.
Several qualitative and quantitative detection methods will be employed to achieve the goal of metabolic profiling in patients with or without sepsis. Principal Components Analysis (PCA) and Partial Least Squares Discrimination Analysis (PLS-DA) methodology will be applied to understand the metabolic profile. The data will be analyzed by Mestrec and MestReNova software package and the Human Metabolome Database (HMDB) searching to identify the biomarkers for the prediction of sepsis. The biomarkers that changed the most will be verified by Liquid Chromatography-Mass Spectrometry (LC-MS).
- Conditions
- Sepsis
- Being tested
- Laboratory diagnostic medicine
- Keywords
- Sepsis, metabolomics, biomarker, prediction, clinical data analysis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory diagnostic medicineDiagnostic test
Metabolomic profiling and laboratory diagnosis including blood routine examination, liver function, renal function, myocardial enzyme, coagulation, arterial blood gas analysis, C-reactive protein, procalcitonin, B-type natriuretic peptide, myoglobin, lipopolysaccharide, cytokines (TNF-α, IL-1β, IL-6, etc.), immune cell markers (CD3+, CD4+, CD8+, etc.), and stool routine as well as intestinal microecology analysis.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Patients admitted in ICU Receives: Diagnostic Test: Laboratory diagnostic medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of sepsis or not
Dynamic assessment of SOFA score to determine whether sepsis occurs. The clinical criteria for sepsis is suspected or documented infection and an acute increase of ≥2 SOFA points.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start10 Jul 2019
- Primary completion18 Jun 2021 (estimated)
- Study completion31 Dec 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xi Peng, Southwest Hospital, China
- Investigators
- Xi Peng, PhD, MD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996759
- Sponsor's protocol ID
- 2018XLC2006
- Acronym
- EPoS
- Status last verified
- Oct 2020
- First submitted
- 23 Jun 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Sepsis by Metabolomic Pofiling in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03996759
- Acronym / sponsor ID
- EPoS / 2018XLC2006
- Conditions
- Sepsis
- Keywords
- Sepsis, metabolomics, biomarker, prediction, clinical data analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xi PengUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 18 Jun 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Jun 2019 (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 serious medical condition associated with a high incidence and mortality rate. It is the leading cause of death in ICU worldwide. Nowadays sepsis was redefined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Despite the progress made in the pathogenesis of sepsis and advances achieved in medical interventions, the management of sepsis remains a challenge for clinicians. The core problem that precludes the promotion in the management of sepsis is the lack of early and precise prediction. The metabolic profiles will be significantly changed when body suffers from sepsis even though the organ function remains normal, thus making it possible to predict sepsis in the early stage through the detection of the metabolites.
Detailed description
In the past the studies on the prediction and prognosis of sepsis were focused on the levels of protein and gene, and few researches have been done in the field of metabolomics. Actually the changes in the functioning of biological systems can be reflected not only by the specifically expressed protein but also by the metabolism. The metabolic characteristic of biological fluids will be significantly changed when body suffers from pathological or physiological stimulation, and these changes can reveal the disease state or severity while the organ function remains normal due to the compensatory action. Therefore it is possible to predict the occurrence, development and prognosis of sepsis in the early stage through the detection of the concentrations or ratios of these metabolites. The traditional methods are difficult to adapt to the detection of such complicated changes in metabolic profiles when sepsis occurs, thus there is a huge demand of novel means for the metabolic profiling in the inflammatory reaction. By now there have been several researches involved in the metabolic profiling in severe wound, but few have been done in the field of critical care medicine. The metabolic profiles in sepsis patients have remained unclear so far. Therefore it is of great significance to develop a metabolic profiling approach for the measurement and interpretation of the metabolites from the biological samples of sepsis patients and to establish a mode for the metabolomics-based early prediction of sepsis.
Several qualitative and quantitative detection methods will be employed to achieve the goal of metabolic profiling in patients with or without sepsis. Principal Components Analysis (PCA) and Partial Least Squares Discrimination Analysis (PLS-DA) methodology will be applied to understand the metabolic profile. The data will be analyzed by Mestrec and MestReNova software package and the Human Metabolome Database (HMDB) searching to identify the biomarkers for the prediction of sepsis. The biomarkers that changed the most will be verified by Liquid Chromatography-Mass Spectrometry (LC-MS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Diagnostic Test: Laboratory diagnostic medicinePatients admitted in ICU |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU.
Key inclusion criteria (4 listed)
- male and female aged 18-80 years old
- confirmed infection (e.g. pulmonary, urinary, blood, abdominal, and pelvic infection)
- APACHE II ≥15 and SOFA < 2 within 24 hours of admission
- ICU length of stay ≥ 3 days
Key exclusion criteria (5 listed)
- pregnant and/or lactating women
- previously suffered from immune diseases and/or long-term use of glucocorticoids
- chronic renal failure or hemodialysis
- patients who expressly refuse consent
- patient who is undergoing other clinical trials
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 |
|---|---|---|
| Laboratory diagnostic medicineMetabolomic profiling and laboratory diagnosis including blood routine examination, liver function, renal function, myocardial enzyme, coagulation, arterial blood gas analysis, C-reactive protein, procalcitonin, B-type natriuretic peptide, myoglobin, lipopolysaccharide, cytokines (TNF-α, IL-1β, IL-6, etc.), immune cell markers (CD3+, CD4+, CD8+, etc.), and stool routine as well as intestinal microecology analysis. | Diagnostic test | Critically ill patients |
Primary outcome
Development of sepsis or not
Time frame: 28 Days
Dynamic assessment of SOFA score to determine whether sepsis occurs. The clinical criteria for sepsis is suspected or documented infection and an acute increase of ≥2 SOFA points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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. This study is not recruiting at the moment.
Xi Peng, PhD, MD principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Xi Peng 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xi Peng, PhD, MD (86-23-68754435, pxlrmm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of sepsis or not (time frame: 28 Days). 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 27 Oct 2020.