- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465003
Cohort Study of Chronic Liver Disease Complicated by Sepsis
March 9, 2026 updated by: The Second Affiliated Hospital of Chongqing Medical University
Use of Antimicrobial Drugs in Severe Infections and Epidemiological Study of Populations With Severe Infections
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
Study Overview
Study Type
Observational
Enrollment (Estimated)
1600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li ShiYing Deputy Chief Physician of the Department of Infectious Disease, Ph.D
- Phone Number: 0086+18623322462
- Email: 302946@hospital.cqmu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Cirrhosis complicated by sepsis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
28-day all-cause mortality in cirrhosis with sepsis
Time Frame: Baseline and 28 days.
|
Baseline and 28 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 25, 2026
Primary Completion (Estimated)
February 25, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
February 10, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 11, 2026
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025IIT204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of California, San FranciscoNational Cancer Institute (NCI)RecruitingSepsis | Sepsis, Severe | Sepsis and Septic Shock | Sepsis at Intensive Care Unit | Sepsis, Septic Shock | Sepsis, Severe Sepsis and Septic Shock | Sepsis With Multiple Organ Dysfunction (MOD) | Sepsis With Acute Organ DysfunctionUnited States
-
Assiut UniversityNot yet recruitingSepsis Induced Myocardial Dysfunction | Sepsis Induced CardiomyopathyEgypt
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityEnrolling by invitationSevere Sepsis | Severe Sepsis Without Septic ShockUnited States