- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05625139
Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results (IPRA)
October 30, 2023 updated by: University Hospital, Strasbourg, France
Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation.
The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room.
Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
34
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
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Strasbourg, France, 67091
- Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
Description
Inclusion criteria:
- Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
- Subject who does not question, after information, the reuse of his data for the purpose of this research
Exclusion criteria:
- Subject having expressed his opposition to participate in the study
- Liver transplant patient hospitalized in the Medical Intensive Care Unit before or after the surgery
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Retrospective description of the protocol of improved rehabilitation after liver transplantation, to study the possibility of its implementation in the anesthesia-intensive care department and to analyze the first results
Time Frame: Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined
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Files analysed retrospectively from December 01, 2018 to August 31, 2020 will be examined
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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)
September 14, 2020
Primary Completion (Actual)
September 14, 2021
Study Completion (Actual)
November 14, 2021
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 14, 2022
First Posted (Actual)
November 22, 2022
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 7906
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.