Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Completed

Conditions

Frailty Syndrome

Cirrhosis of the Liver

Sarcopenia

Treatments

Combination Product: No specific intervention.

Combination Product: Branched-chain amino acids (BCAA)

Combination Product: Multispecies probiotic: Vivomixx®

Combination Product: Home exercise program for 12 months.

Study type

Interventional

Funder types

Other

Identifiers

NCT04243148

IIBSP-FRA-2019-36

Details and patient eligibility

About

This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs.

Full description

Substudy I. The phase angle (PA) determined by electrical bioimpedance is an index of FS with prognostic value in outpatients with cirrhosis, but its usefulness in hospitalized patients has not been studied. Objective: To analyze the prognostic value of PA in hospitalized patients with cirrhosis. Patients and Methods: 100 hospitalized patients with cirrhosis will be consecutively included and PA will be determined by bioimpedance at admission. The correlation between PA and liver function and frailty markers, and the evolution during hospitalization, as well as the incidence of falls, hospitalizations and mortality during follow-up will be analyzed. Substudy II. Given the multidimensional nature of the FS, we propose a multifactorial non-pharmacological intervention based on evidence from previous studies that could be implemented in daily clinical practice. Objective: To evaluate if a multifactorial intervention can improve the FS and decrease the related events (hospitalizations, falls and mortality) in patients with cirrhosis. Patients and Methods: 150 outpatients with cirrhosis will be included and evaluated using the Liver Frailty Index. Frail and pre-frail patients will be randomized into two groups: one group that will receive a multifactorial intervention, consisting of exercise at home, branched-chain amino acids and multispecies probiotic for one year, and one control group. The evolution of the Liver Frailty Index and other parameters (muscle and cognitive function, bioimpedance, risk of falls, quality of life) and biomarkers (miostatin, immune response, microbiota) of FS, and the incidence of hospitalizations, falls and mortality in both groups will be prospectively analyzed.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients
Aged >18 years old, with cirrhosis diagnosed by clinical, analytical and ultrasound criteria or liver biopsy
Conscious and oriented in time and space and able to understand and follow the indications of the study.

Exclusion criteria

Liver cirrhosis with poor prognosis (MELD [Model for End Stage Liver Disease]> 25)
Hepatocellular carcinoma or other active neoplastic disease
Expected survival <6 months
Acute and/or chronic hepatic encephalopathy
Neurological disorder that hinders the performance of the tests
Active alcoholism in the previous 3 months
Severe comorbidities
Hospitalization in the previous month
Contraindications to exercise or probiotic treatment (immunosuppression)
Refusal to sign informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 2 patient groups

Multifactorial intervention

Experimental group

Description:

Frail and pre-frail patients will receive multifactorial intervention consisting of home exercise, BCAA supplements and a multispecies probiotic for 12 months.

Treatment: