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

Overview

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).

Interventions

• Dietary supplement Dietary management
  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
• Other No dietary management
  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.

Primary outcome measures

• 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). [Time frame: 3rd month after visit 1.]

Secondary outcome measures (8)

• Evaluate the impact of a nutritional follow-up on the fragility of patients at 6 months on list [Time frame: 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 [Time frame: 3rd Month (M3) after Visit 1 and M6 after V1]
• Evaluate compliance with oral nutritional supplement treatment for patients awaiting transplant [Time frame: 3rd Month and 6th month after Visit 1]
• Evaluate the relationship between fragility and severity of liver disease (MELD score) [Time frame: Day 0, 3rd Month (M3) and 6th Month (M6)]
• Evaluate the relationship between fragility and access to a transplant [Time frame: Day 0, Month 3 after Visit 1, Month 6 after Visit 1]
• Evaluate the relationship between fragility and mortality on waiting list of transplantation or leaving the list due to worsening [Time frame: Day 0, 3rd month and 6th month]
• Evaluate the relationship between frailty and unscheduled hospitalizations while waiting for Liver Transplantation [Time frame: Day 0, 3rd month and 6th month after Visit 1]
• Evaluate the satisfaction of dieticians in carrying out nutritional monitoring for patients waiting for liver transplantation (logistics of organizing consultations and teleconsultations) [Time frame: study completion at Month 30]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Hôpital de la Croix Rousse / GHN — Lyon

Identifiers

NCT: NCT06911619 · 69HCL24_1201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗