Cohort Study of Chronic Liver Disease Complicated by Sepsis | NCT07465003

Studies
Cohort Study of Chronic Liver Disease Complicated by Sepsis

NCT07465003

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Status

Not yet recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Cirrhosis
Sepsis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2026Estimated

Primary Completion Date

Feb 25, 2027Estimated

Completion Date

Jun 1, 2028Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study population: Patients with liver cirrhosis complicated by sepsis Observation indicators: Fluid resuscitation strategy, early dynamic indicators such as MAP Observation endpoint: 28-day all-cause mortality Study design: Retrospective cohort study

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day all-cause mortality in cirrhosis with sepsis		Baseline and 28 days.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically or pathologically diagnosed with cirrhosis;
meets the Sepsis-3 diagnostic criteria.

Exclusion Criteria:

Combined organ transplantation, active malignant tumors;
Pregnant or breastfeeding women;
Long-term use of immunosuppressants (non-steroidal);
Death or voluntary discharge within 24 hours of admission;
Incomplete data.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cirrhosis complicated by sepsis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li ShiYing Deputy Chief Physician of the Department of Infectious Disease, Ph.D	Contact	0086+18623322462		302946@hospital.cqmu.edu.cn

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37088310	Background	Maiwall R, Rao Pasupuleti SS, Hidam AK, Kumar A, Tevethia HV, Vijayaraghavan R, Majumdar A, Prasher A, Thomas S, Mathur RP, Kumar G, Sarin SK. A randomised-controlled trial (TARGET-C) of high vs. low target mean arterial pressure in patients with cirrhosis and septic shock. J Hepatol. 2023 Aug;79(2):349-361. doi: 10.1016/j.jhep.2023.04.006. Epub 2023 Apr 23.
35460725

ID	Term
D005355	Fibrosis
D018805	Sepsis

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome