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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04243148
Study type Interventional
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact
Status Completed
Phase N/A
Start date May 13, 2020
Completion date May 30, 2023

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