Role of the Kallikrein-kinin System in Septic Cardiomyopathy

NCT06080282 | Completed DMC

• 1 other identifier: TJ-IRB202308109
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

sepsis; Septic cardiomyopathy; KKS

Outcome Measures

Primary Outcomes (1)

• Incidence of Sepsis-Induced Cardiomyopathy (SIC)

  Number of participants who develop sepsis-induced cardiomyopathy during their ICU stay

  During ICU stay (assessed up to day 28)

Secondary Outcomes (3)

• Plasma Levels of KKS Pathway Proteins (KLK1/B1R/Bradykinin/iNOS)

  Baseline (within 24 hours of admission)

• 28-Day All-Cause Mortality

  28 days

• Echocardiographic Parameters of Cardiac Function

  Baseline (within 24 hours of admission)

Study Arms (2)

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.

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.

Interventions

Ulinastatin DRUG

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.

Sepsis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critical ill patients without sepsis; Patients with sepsis and patients diagnosed with septic cardiomyopathy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qin Zhang: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess blood from patient blood gas analysis, followed by separation of plasma.

MeSH Terms

Conditions

Sepsis

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• QIN Zhang, phd

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phd

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: June 1, 2017
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (1)