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

NCT06948565 | Recruiting

• 1 other identifier: 2024/908
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Intensive Care Medicine; Acute on Chronic Liver Failure(ACLF)

Keywords

prognosis; cirrhosis; ICU; ACLF

Outcome Measures

Primary Outcomes (1)

• 28-day survival

  28 days

Secondary Outcomes (7)

• Phenotype of patients admitted to intensive care

  baseline

• Overall survival

  through study completion

• Survival without liver transplantation

  12 months

• Proportion of patients listed for liver transplantation

  through study completion

• number of patients receiving LT

  through study completion

Interventions

observational study OTHER

This observational study aims to describe the clinical practices and the outcome of patients admitted in ICU.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Fibrosis; Acute-On-Chronic Liver Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: April 29, 2025
• Study Start: August 8, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2024-11

Locations

FR (1)