Actively Recruiting
Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
Led by Hospices Civils de Lyon · Updated on 2025-07-04
210
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cirrhosis is a major public health issue responsible for about 15000 deaths each year. Liver transplantation (LT) remains the only curative treatment for decompensated cirrhosis. Decompensated cirrhotic patients awaiting LT are malnourished, sarcopenic and fragile. The evaluation of the nutritional status of these patients is complex because the anthropometric data that define undernutrition (weight variation, BMI) are often compromised by the presence of edema and ascites related to liver disease. It therefore seems appropriate to focus on the fragility and sarcopenia of the cirrhotic patient as a reflection of the nutritional status. In 2017, the American team of Lai et al. validated a Liver fraily index (LFI) score of frailty specific to cirrhotic patients waiting for LT. The LFI is composed of three simple physical tests (Grip test, chair lift test, and balance tests) performed at the patient's bedside, which results in a quantitative and reproducible frailty score. Frailty while waiting for LT is associated with an increase in mortality on the waiting list, independently of the MELD (Model for End stage Liver disease) score, which is a reflection of liver severity. About half of the patients who are candidates for LT will present an aggravation of their frailty while waiting for LT. To date, no study has reported the results of a nutritional intervention on the evolution of fragility in patients awaiting LT. The objective of our study is to evaluate the impact of a nutritional management and follow-up by a dietitian specialized in hepatology on the fragility of patients waiting for LT. This is a monocentric study, randomized in two parallel groups (an intervention group with nutritional follow-ups by a trained dietitian and a control group with follow-up by the reference hepatologist without specific dietary management by a dietician) in open. All patients enrolled on the LT list with an LFI \> 3.2 (pre-frail and frail state) will be included in the study. It is planned to include 210 patients over a period of 24 months. The LFI will be measured for all patients (control group + intervention group) at 3 and 6 months, as part of their follow-up in the LT center. This study will also make it possible to correlate frailty with other parameters (severity of liver disease, access to LT).
CONDITIONS
Official Title
Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 65 18 years
- Registered on the waiting list for Hepatic Transplantation at the Transplantation center of the Croix Rousse Hospital (GHN), Hospices Civils de Lyon
- Signed a dated informed consent
- Affiliated to a social security scheme or equivalent
You will not qualify if you...
- Hospitalized in intensive care
- Initial LFI test result less than 3.2 (considered robust)
- Unable to perform LFI exercises due to chronic or acute motor disability in limbs
- Pregnant, parturient, or lactating women
- Deprived of liberty by judicial or administrative decision
- Under psychiatric care
- Admitted to a health or social institution for reasons other than research
- Subject to legal protection measures (guardianship, curatorship)
- Unable to understand protocol information
- Participating in another interventional research with ongoing exclusion period at inclusion
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Trial Site Locations
Total: 1 location
1
Hôpital de la Croix Rousse / GHN
Lyon, France, 69004
Actively Recruiting
Research Team
M
Maxime PATUREL, Diététicien, FF CDS
CONTACT
M
Mahutondji Calèbe SOMASSE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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