CirrhosisREACIRRHOSENCT06948565
Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study
An observational study of Cirrhosis and Intensive Care Medicine, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cirrhosis, Intensive Care Medicine, Acute on Chronic Liver Failure(ACLF)
- What is being tested?
- observational study
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cirrhosis admitted to intensive care between January 2014 and December 2024.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Delphine Weil Verhoeven, MD, PhD, +33381669457, dweil@chu-besancon.fr
Thomas Lelong
About this study
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.
- Being tested
- observational study
- Keywords
- prognosis, cirrhosis, ICU, ACLF
- Medical subject headings
- Fibrosis, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
This observational study aims to describe the clinical practices and the outcome of patients admitted in ICU.
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day survival
Measured: 28 days
Secondary outcomes (7)
Phenotype of patients admitted to intensive care
Measured: baseline
Overall survival
Measured: through study completion
Survival without liver transplantation
Measured: 12 months
Proportion of patients listed for liver transplantation
Measured: through study completion
number of patients receiving LT
Measured: through study completion
Prognostic performance of general and cirrhosis-specific organ failure scores
Measured: baseline
Comparison of the characteristics of patients on admission in primary care hospitals and in university hospital.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start8 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948565
- Sponsor's protocol ID
- 2024/908
- Acronym
- REACIRRHOSE
- Status last verified
- Nov 2024
- First submitted
- 3 Jan 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT06948565
- Acronym / sponsor ID
- REACIRRHOSE / 2024/908
- Keywords
- prognosis, cirrhosis, ICU, ACLF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cirrhosis admitted to intensive care between January 2014 and December 2024.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyThis observational study aims to describe the clinical practices and the outcome of patients admitted in ICU. | Other | – |
Primary outcome
28-day survival
Time frame: 28 days
7 secondary outcomes
Phenotype of patients admitted to intensive care
Time frame: baseline
Overall survival
Time frame: through study completion
Survival without liver transplantation
Time frame: 12 months
Proportion of patients listed for liver transplantation
Time frame: through study completion
number of patients receiving LT
Time frame: through study completion
Prognostic performance of general and cirrhosis-specific organ failure scores
Time frame: baseline
Comparison of the characteristics of patients on admission in primary care hospitals and in university hospital.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Intensive Care Medicine, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.