SepsisNCT06080282
Role of the Kallikrein-kinin System in Septic Cardiomyopathy
An observational study of Sepsis, run by Qin Zhang at 1 site in China.
Trial summary
The purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (KKS) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- How many people
- 567 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 14 Oct 2024
- How long will I take part?
- 28 Days
- 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: Critical ill patients without sepsis; Patients with sepsis and patients diagnosed with septic cardiomyopathy.
Who may be able to join
- Age >= 18 years old.
- Admitted to the Intensive Care Unit (ICU) with an anticipated length of stay exceeding 24 hours.
- Patient or legally authorized representative provides written informed consent prior to enrollment.
- Categorized into one of the following three mutually exclusive cohorts within 24 hours of ICU admission:
- Cohort 1 (Non-sepsis Controls): Admitted for definitive non-infectious etiologies (e.g., severe trauma, major non-cardiac surgery) with no clinical or microbiological evidence of infection throughout the ICU stay.
- Cohort 2 (Sepsis without SIC): Diagnosed with sepsis according to the Sepsis-3 criteria (acute change in SOFA score >= 2 points driven by infection), but with normal cardiac troponin levels and preserved cardiac function.
- Cohort 3 (Sepsis-Induced Cardiomyopathy, SIC): Diagnosed with sepsis according to the Sepsis-3 criteria, accompanied by new-onset myocardial injury (elevated cardiac troponin above the upper limit of normal) and/or echocardiographic evidence of myocardial dysfunction directly attributable to sepsis.
Who cannot join
- Pre-existing severe chronic cardiac conditions, including history of cardiac surgery, severe pre-existing heart failure (NYHA Class III or IV), persistent severe arrhythmias, or known primary cardiomyopathy (e.g., hypertrophic or dilated cardiomyopathy).
- Acute non-infectious cardiovascular or cerebrovascular events prior to or upon ICU admission, such as acute myocardial infarction (Type 1), acute ischemic/hemorrhagic stroke, or cardiac arrest.
- Severe end-stage comorbidities, including end-stage renal disease (ESRD) requiring chronic maintenance dialysis prior to this illness, Child-Pugh Class C hepatic cirrhosis, or advanced malignant tumors with a life expectancy < 3 months.
- History of paraquat poisoning or other toxic ingestions known to directly cause profound myocardial or pulmonary toxicity.
- Pregnant or breastfeeding women.
- Indeterminate or ambiguous infectious status (e.g., cases treated with empiric antibiotics for suspected infection but where infection could neither be confirmed nor ruled out), excluded to prevent misclassification bias.
- Intellectual, psychological, or neurological disorders that preclude necessary clinical examinations or compliance with study procedures.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
The purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (KKS) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes.
Read the detailed description
This prospective observational study enrolled 567 critically ill adults within 24 hours of their intensive care unit (ICU) admission across three medical centers in Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China)Wuhan, China. Recruitment occurred during two distinct periods: June 2017 to September 2018 and September 2023 to October 2024. Patients were categorized according to Sepsis-3.0 criteria into non-sepsis and sepsis groups. The non-sepsis control group comprised individuals without evidence of infection whose Sequential Organ Failure Assessment (SOFA) scores remained below 2 points. Exclusion criteria included: 1) paraquat poisoning; 2) age under 18 years at diagnosis; 3) acute cardiovascular and cerebrovascular diseases unrelated to inflammation; 4) history of cardiac surgery; 5) pregnancy or breastfeeding; and 6) intellectual or psychological disorders precluding suitable study participation. Within the sepsis cohort, patients meeting the Sepsis-3 criteria who concurrently developed new-onset myocardial injury (troponin elevation exceeding the upper limit of normal, e.g., > 0.05 ng/mL) and/or echocardiographic evidence of myocardial dysfunction (ejection fraction < 50%) or B-type natriuretic peptide (BNP) > 500 pg/mL directly attributable to sepsis. All echocardiographic assessments were performed by accredited sonographers from the Tongji Clinic Echo Lab, with subsequent interpretations conducted by board-certified cardiologists from the same institution.
During the study periods, a total of 652 ICU patients were initially assessed for eligibility. Based on our predefined criteria, 85 patients were excluded: meeting absolute exclusion criteria (n = 18), failing to meet specific strict group definitions (n = 14), declining to participate or missing informed consent (n = 19), lacking baseline plasma samples within 24 hours (n = 16), and having incomplete echocardiographic or core clinical data (n = 18). Ultimately, 567 critically ill patients were enrolled, comprising 417 septic patients (including 104 who developed SIC) and 150 non-septic controls.
- Conditions
- Sepsis
- Being tested
- Ulinastatin
- Keywords
- sepsis; Septic cardiomyopathy; KKS
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Observational exposure. Ulinastatin was administered intravenously based solely on the attending physicians' clinical judgment during routine care, typically at a dosage of 500,000 U, once daily (qd). It was not assigned by a predefined study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Critically ill patients diagnosed with sepsis. In this observational cohort, a subset of these patients received Ulinastatin based solely on the attending physicians' clinical experience and standard routine care, rather than a predefined study protocol. For those who received the treatment, the typical regimen was Ulinastatin (intravenous), 500,000 U, once daily (qd) during their ICU stay. Receives: Drug: Ulinastatin | |
| Controls | Critically ill patients without sepsis admitted to the ICU. These patients received standard intensive care appropriate for their primary diagnoses and did not receive Ulinastatin treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sepsis-Induced Cardiomyopathy (SIC)
Number of participants who develop sepsis-induced cardiomyopathy during their ICU stay
Measured: During ICU stay (assessed up to day 28)
Secondary outcomes (3)
Plasma Levels of KKS Pathway Proteins (KLK1/B1R/Bradykinin/iNOS)
Concentrations of KLK1, B1R, bradykinin, and iNOS measured in plasma to investigate the mechanistic pathway through which Ulinastatin suppresses sepsis-induced cardiomyopathy.
Measured: Baseline (within 24 hours of admission)
28-Day All-Cause Mortality
Overall survival status evaluated at 28 days following ICU admission.
Measured: 28 days
Echocardiographic Parameters of Cardiac Function
Quantitative assessment of Echocardiographic Parameters of Cardiac Function, such as Left Ventricular Ejection Fraction (LVEF) used for SIC diagnosis.
Measured: Baseline (within 24 hours of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Jun 2017
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
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
- 567 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- QIN Zhang, phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080282
- Sponsor's protocol ID
- TJ-IRB202308109
- Status last verified
- Jul 2026
- First submitted
- 6 Oct 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT06080282
- Acronym / sponsor ID
- TJ-IRB202308109
- Conditions
- Sepsis
- Keywords
- sepsis; Septic cardiomyopathy; KKS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 12 Oct 2023 (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.
The purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (KKS) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes.
Detailed description
This prospective observational study enrolled 567 critically ill adults within 24 hours of their intensive care unit (ICU) admission across three medical centers in Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China)Wuhan, China. Recruitment occurred during two distinct periods: June 2017 to September 2018 and September 2023 to October 2024. Patients were categorized according to Sepsis-3.0 criteria into non-sepsis and sepsis groups. The non-sepsis control group comprised individuals without evidence of infection whose Sequential Organ Failure Assessment (SOFA) scores remained below 2 points. Exclusion criteria included: 1) paraquat poisoning; 2) age under 18 years at diagnosis; 3) acute cardiovascular and cerebrovascular diseases unrelated to inflammation; 4) history of cardiac surgery; 5) pregnancy or breastfeeding; and 6) intellectual or psychological disorders precluding suitable study participation. Within the sepsis cohort, patients meeting the Sepsis-3 criteria who concurrently developed new-onset myocardial injury (troponin elevation exceeding the upper limit of normal, e.g., > 0.05 ng/mL) and/or echocardiographic evidence of myocardial dysfunction (ejection fraction < 50%) or B-type natriuretic peptide (BNP) > 500 pg/mL directly attributable to sepsis. All echocardiographic assessments were performed by accredited sonographers from the Tongji Clinic Echo Lab, with subsequent interpretations conducted by board-certified cardiologists from the same institution.
During the study periods, a total of 652 ICU patients were initially assessed for eligibility. Based on our predefined criteria, 85 patients were excluded: meeting absolute exclusion criteria (n = 18), failing to meet specific strict group definitions (n = 14), declining to participate or missing informed consent (n = 19), lacking baseline plasma samples within 24 hours (n = 16), and having incomplete echocardiographic or core clinical data (n = 18). Ultimately, 567 critically ill patients were enrolled, comprising 417 septic patients (including 104 who developed SIC) and 150 non-septic controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Drug: UlinastatinCritically ill patients diagnosed with sepsis. In this observational cohort, a subset of these patients received Ulinastatin based solely on the attending physicians' clinical experience and standard routine care, rather than a predefined study protocol. For those who received the treatment, the typical regimen was Ulinastatin (intravenous), 500,000 U, once daily (qd) during their ICU stay. |
| Controls | – | –Critically ill patients without sepsis admitted to the ICU. These patients received standard intensive care appropriate for their primary diagnoses and did not receive Ulinastatin treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients without sepsis; Patients with sepsis and patients diagnosed with septic cardiomyopathy.
Key inclusion criteria (7 listed)
- Age >= 18 years old.
- Admitted to the Intensive Care Unit (ICU) with an anticipated length of stay exceeding 24 hours.
- Patient or legally authorized representative provides written informed consent prior to enrollment.
- Categorized into one of the following three mutually exclusive cohorts within 24 hours of ICU admission:
Key exclusion criteria (7 listed)
- Pre-existing severe chronic cardiac conditions, including history of cardiac surgery, severe pre-existing heart failure (NYHA Class III or IV), persistent severe arrhythmias, or known primary cardiomyopathy (e.g., hypertrophic or dilated cardiomyopathy).
- Acute non-infectious cardiovascular or cerebrovascular events prior to or upon ICU admission, such as acute myocardial infarction (Type 1), acute ischemic/hemorrhagic stroke, or cardiac arrest.
- Severe end-stage comorbidities, including end-stage renal disease (ESRD) requiring chronic maintenance dialysis prior to this illness, Child-Pugh Class C hepatic cirrhosis, or advanced malignant tumors with a life expectancy < 3 months.
- History of paraquat poisoning or other toxic ingestions known to directly cause profound myocardial or pulmonary toxicity.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| UlinastatinObservational exposure. Ulinastatin was administered intravenously based solely on the attending physicians' clinical judgment during routine care, typically at a dosage of 500,000 U, once daily (qd). It was not assigned by a predefined study protocol. | Drug | Sepsis |
Primary outcome
Incidence of Sepsis-Induced Cardiomyopathy (SIC)
Time frame: During ICU stay (assessed up to day 28)
Number of participants who develop sepsis-induced cardiomyopathy during their ICU stay
3 secondary outcomes
Plasma Levels of KKS Pathway Proteins (KLK1/B1R/Bradykinin/iNOS)
Time frame: Baseline (within 24 hours of admission)
28-Day All-Cause Mortality
Time frame: 28 days
Echocardiographic Parameters of Cardiac Function
Time frame: Baseline (within 24 hours of admission)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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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.
QIN Zhang, phd principal investigator
Tongji Hospital
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 Qin Zhang 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Sepsis-Induced Cardiomyopathy (SIC) (time frame: During ICU stay (assessed up to day 28)). 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 28 Jul 2026.