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Not yet recruiting NCT07465003

Cohort Study of Chronic Liver Disease Complicated by Sepsis

— Observational Cirrhosis Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cirrhosis, Sepsis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Use of Antimicrobial Drugs in Severe Infections and Epidemiological Study of Populations With Severe Infections

Overview

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

Primary outcome measures

  • 28-day all-cause mortality in cirrhosis with sepsis [Time frame: Baseline and 28 days.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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: 1 PMID 28114553
  • 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

Identifiers

NCT: NCT07465003 · 2025IIT204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗