Clinical trial NCT06911619: Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
Official title: Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fragility
Cirrhosis
Hepatic Transplantation
Undernutrition
Keywords: nutrition
Hepatic Transplantation
Cirrhosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective interventional, single-center, randomized, longitudinal study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient registered on the waiting list for Hepatic Transplantation in the Transplantation center of the Croix Rousse Hospital (GHN), Hospices Civils de Lyon
* Dated and signed an informed consent
* Affiliated to a social security scheme or beneficiary of a similar scheme

Exclusion Criteria:

* Patient hospitalized in intensive care
* Patient with initial LFI test result \< to 3.2, that is considered as "robust".
* Patient unable to perform LFI exercises (chronic or acute motor disability in lower or upper limbs)
* Pregnant, parturient or lactating women
* Persons deprived of liberty by a judicial or administrative decision
* Persons under psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)
* Inability to understand protocol information
* Subject participating in another interventional research including an ongoing exclusion period at inclusion

Primary outcomes:
measure: Evaluate the impact at 3 months, of a nutritional management and follow-up by a dietitian specialized in hepatology compared to the usual management without dietary follow-up, on the fragility of patients waiting for liver transplantation (LT).
timeFrame: 3rd month after visit 1.
Secondary outcomes:
measure: Evaluate the impact of a nutritional follow-up on the fragility of patients at 6 months on list
timeFrame: 6th Month after visit 1.
measure: Evaluate the impact of a nutritional follow-up on the distribution of patients' frailty according to classes: robust, pre-fragile, fragile
timeFrame: 3rd Month (M3) after Visit 1 and M6 after V1
measure: Evaluate compliance with oral nutritional supplement treatment for patients awaiting transplant
timeFrame: 3rd Month and 6th month after Visit 1
measure: Evaluate the relationship between fragility and severity of liver disease (MELD score)
timeFrame: Day 0, 3rd Month (M3) and 6th Month (M6)
measure: Evaluate the relationship between fragility and access to a transplant
timeFrame: Day 0, Month 3 after Visit 1, Month 6 after Visit 1
measure: Evaluate the relationship between fragility and mortality on waiting list of transplantation or leaving the list due to worsening
timeFrame: Day 0, 3rd month and 6th month
measure: Evaluate the relationship between frailty and unscheduled hospitalizations while waiting for Liver Transplantation
timeFrame: Day 0, 3rd month and 6th month after Visit 1
measure: Evaluate the satisfaction of dieticians in carrying out nutritional monitoring for patients waiting for liver transplantation (logistics of organizing consultations and teleconsultations)
timeFrame: study completion at Month 30
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse / GHN
Study officials:
affiliation: Service Rééducation Nutritionnelle Hôpital de la Croix Rousse / GHN
name: Maxime PATUREL
role: PRINCIPAL_INVESTIGATOR
References: