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RecruitingNCT06948565REACIRRHOSEUpdated Aug 11, 2025

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

An observational study in Cirrhosis, Intensive Care Medicine and Acute on Chronic Liver Failure(ACLF), sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Sex
All
01

Study 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.
02

Conditions studied

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

Keywords

  • prognosis
  • cirrhosis
  • ICU
  • ACLF
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's planned enrollment of 500 is above the median of 110 across 973 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Otherobservational study

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

06

What researchers measure

Primary outcomes

  1. 28-day survival

    Time frame: 28 days

Secondary outcomes

  1. Phenotype of patients admitted to intensive care

    Time frame: baseline

  2. Overall survival

    Time frame: through study completion

  3. Survival without liver transplantation

    Time frame: 12 months

  4. Proportion of patients listed for liver transplantation

    Time frame: through study completion

  5. number of patients receiving LT

    Time frame: through study completion

  6. Prognostic performance of general and cirrhosis-specific organ failure scores

    Time frame: baseline

  7. Comparison of the characteristics of patients on admission in primary care hospitals and in university hospital.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • CHU de Besançon
    Besançon, 25000, France
    • Delphine Weil Verhoeven, MD, PhD · Contact · dweil@chu-besancon.fr · +33381669457
    • Thomas Lelong · Principal investigator
    • Delphine Weil Verhoeven, MD PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06948565
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Apr 29, 2025
Start date
Aug 8, 2025
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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