Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study (REACIRRHOSE)

Ten years after our team's publication, practices have changed considerably in the management of severe cirrhotic patients. This study will analyse these practices in primary care hospitals and in a tertiary centre, and assess the impact of these changes on the prognosis of these patients.

The following hypotheses will be tested:

  • Improvement in intensive care and overall prognosis compared with data from the literature prior to 2014
  • Improved access to liver transplantation compared with the literature prior to 2014
  • Improvement in intensive care unit practices (for example: application of recommendations published by learned societies concerning the intensive care unit management of patients with cirrhosis, access to comfort care, degree of clinical severity on admission to the intensive care unit, etc.).
  • Centre' effect: variability in the phenotype of patients admitted to intensive care depending on the technical facilities available and whether or not the hospital centre has access to TH.

Study Overview

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France, 25000
        • Recruiting
        • CHU de Besancon
        • Contact:
        • Principal Investigator:
          • Thomas Lelong
        • Sub-Investigator:
          • Delphine Weil Verhoeven, MD PhD

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

No

Sampling Method

Probability Sample

Study Population

Patients with cirrhosis admitted to intensive care between January 2014 and December 2024.

Description

Inclusion Criteria:

Patients with cirrhosis over 18 years of age (cirrhosis either histologically proven or diagnosed by hepatologists according to clinical, biological and ultrasound criteria) admitted to intensive care between January 2014 and December 2024.

Exclusion Criteria:

None

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 survival
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Phenotype of patients admitted to intensive care
Time Frame: baseline
baseline
Overall survival
Time Frame: through study completion
through study completion
Survival without liver transplantation
Time Frame: 12 months
12 months
Proportion of patients listed for liver transplantation
Time Frame: through study completion
through study completion
number of patients receiving LT
Time Frame: through study completion
through study completion
Prognostic performance of general and cirrhosis-specific organ failure scores
Time Frame: baseline
baseline
Comparison of the characteristics of patients on admission in primary care hospitals and in university hospital.
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

August 8, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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