Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)

NCT06911619 | Recruiting

• 1 other identifier: 69HCL24_1201
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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).

Conditions

Fragility; Cirrhosis; Hepatic Transplantation; Undernutrition

Keywords

nutrition; Hepatic Transplantation; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Measurement of LFI (Liver fraily index) score score variation between D0 (baseline = visit 1) and 3 months (first reassessment = visit 2) during the liver transplantation waiting period. This variation will be compared between the intervention group and the control group.

  3rd month after visit 1.

Secondary Outcomes (8)

• Evaluate the impact of a nutritional follow-up on the fragility of patients at 6 months on list

  6th Month after visit 1.

• Evaluate the impact of a nutritional follow-up on the distribution of patients' frailty according to classes: robust, pre-fragile, fragile

  3rd Month (M3) after Visit 1 and M6 after V1

• Evaluate compliance with oral nutritional supplement treatment for patients awaiting transplant

  3rd Month and 6th month after Visit 1

• Evaluate the relationship between fragility and severity of liver disease (MELD score)

  Day 0, 3rd Month (M3) and 6th Month (M6)

• Evaluate the relationship between fragility and access to a transplant

  Day 0, Month 3 after Visit 1, Month 6 after Visit 1

Study Arms (2)

Dietary intervention Group

EXPERIMENTAL

The intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy. Follow-up visits in person, carried out by the dietician at the 3rd and 6th month waiting for liver transplantation and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (oral nutritional supplement, enteral or parenteral nutrition)

Dietary Supplement: Dietary management

Standard Follow up

OTHER

The patient will be followed up by his referee hepatologist every 3 months. The 3-month and 6-month follow-up visits pending transplantation will be performed with a Clinical Research Assistant on the same day as the follow-up consultation with his hepatologist with the completion of the LFI test and the collection of intercurrent events and the re-evaluation of the liver disease.

Other: No dietary management

Interventions

Dietary management DIETARY_SUPPLEMENT

The intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy every month. Follow-up visits in person, carried out by the dietitian at the 3rd and 6th month waiting for transplant and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (CNO, enteral or parenteral nutrition)

Dietary intervention Group

No dietary management OTHER

The patient will be followed up by his reference hepatologist every 3 months. Follow-up visits at 3 months and 6 months waiting for liver transplantation will be performed by Clinical Research assistant on the same day as the follow-up consultation with his hepatologist with the completion of the Liver Frailty Index test and the collection of intercurrent events and the reassessment of liver disease.

Also known as: Liver Frailty Index

Standard Follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse / GHN

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Fibrosis; Malnutrition

Interventions

Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Maxime PATUREL

  Service Rééducation Nutritionnelle Hôpital de la Croix Rousse / GHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime PATUREL, Diététicien, FF CDS

CONTACT

+33 (0)4 72 07 25 43; maxime.paturel@chu-lyon.fr

Mahutondji Calèbe SOMASSE

CONTACT

+33 (0)4 72 07 13 36; mahutondji-calebe.somasse@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective interventional, single-center, randomized, longitudinal study

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

FR (1)