NCT06080282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

7.4 years

First QC Date

October 6, 2023

Last Update Submit

March 24, 2026

Conditions

Keywords

sepsis; Septic cardiomyopathy; KKS

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival

    28 days

Secondary Outcomes (1)

  • Cardiac function

    24 hour

Study Arms (2)

Sepsis

No intervention

Controls

Non-septic controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • (1) Age range greater than 18 years. (2) Patients diagnosed with septic cardiomyopathy. (3) Clear determination of the cause of myocardial injury, such as the source of infection, bacterial culture results, etc. (4) Patients who are capable of cooperating and completing the necessary examinations and treatments.

You may not qualify if:

  • (1) Presence of other significant underlying cardiovascular diseases, such as coronary heart disease, heart failure, etc. (2) Presence of other organ dysfunction that poses a significant threat to life, such as respiratory failure, liver failure, etc. (3) Presence of severe infections or inflammatory diseases unrelated to myocardial injury, such as severe acute pancreatitis. (4) History of receiving interventional treatments, such as immunomodulatory agents, anti-inflammatory drugs, etc. (5) Pregnant or lactating women. (6) Pediatric patients who are under the age of majority.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological 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

March 30, 2026

Record last verified: 2026-03

Locations