Risk Factors for Adverse Outcomes in Sepsis

NCT06541600 | Completed

• 1 other identifier: TJ-IRB20230823
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-phase prospective study utilized Data-Independent Acquisition proteomics on a nested subset (15 SIC vs. 15 matched sepsis) to map early molecular alterations. Guided by gene-set enrichment evidence of extracellular matrix (ECM) disruption as a pathway-derived biomarker. Admission matrix metalloproteinase-3 was validated in 567 critically ill patients (417 sepsis, 150 non-septic controls) across three hospital campuses.

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 (2)

• Plasma Levels of MMP3

  Baseline (within 24 hours of admission), Day 3, and Day 7

• Survival

  28 days

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

Non-septic controls

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+
• 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

Human blood plasma obtained from whole blood collected in EDTA tubes, separated by centrifugation, and stored at -80°C. Aliquots are intended for downstream molecular and biomarker analyses.

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: August 7, 2024
• 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)