Cohort Study of Chronic Liver Disease Complicated by Sepsis

NCT07465003 | Not Yet Recruiting

• 1 other identifier: 2025IIT204
• Study Type: observational
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cirrhosis; Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality in cirrhosis with sepsis

  Baseline and 28 days.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cirrhosis complicated by sepsis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Related Publications (4)

• 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.

  PMID: 37088310 BACKGROUND

• Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK. A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. J Hepatol. 2022 Sep;77(3):670-682. doi: 10.1016/j.jhep.2022.03.043. Epub 2022 Apr 20.

  PMID: 35460725 BACKGROUND

• Raith EP, Udy AA, Bailey M, McGloughlin S, MacIsaac C, Bellomo R, Pilcher DV; Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcomes and Resource Evaluation (CORE). Prognostic Accuracy of the SOFA Score, SIRS Criteria, and qSOFA Score for In-Hospital Mortality Among Adults With Suspected Infection Admitted to the Intensive Care Unit. JAMA. 2017 Jan 17;317(3):290-300. doi: 10.1001/jama.2016.20328.

  PMID: 28114553 BACKGROUND

• Piano S, Tonon M, Angeli P. Changes in the epidemiology and management of bacterial infections in cirrhosis. Clin Mol Hepatol. 2021 Jul;27(3):437-445. doi: 10.3350/cmh.2020.0329. Epub 2021 Jan 28.

  PMID: 33504138 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Li ShiYing Deputy Chief Physician of the Department of Infectious Disease, Ph.D

CONTACT

0086+18623322462; 302946@hospital.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 11, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share