- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06948565
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
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- CHU de Besancon
-
Contact:
- Delphine Weil Verhoeven, MD, PhD
- Phone Number: +33381669457
- Email: dweil@chu-besancon.fr
-
Principal Investigator:
- Thomas Lelong
-
Sub-Investigator:
- Delphine Weil Verhoeven, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/908
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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