Clinical trial NCT04243148: Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention
Official title: Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of a Multifactorial Intervention (Home Exercise, Branched-chain Aminoacids and Probiotic)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis of the Liver
Sarcopenia
Frailty Syndrome
Keywords: Falls
Hospitalizations
Mortality
Phase angle
Body Composition
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Substudy I: Mortality during hospitalization and follow-up
timeFrame: One year
measure: Substudy II: Evolution of the Liver Frailty Index.
timeFrame: One year
Secondary outcomes:
measure: Phase angle (PA)
timeFrame: One year
measure: Degree of sarcopenia
timeFrame: One year
measure: Biomarkers of frailty
timeFrame: One year
measure: Fall risk tests
timeFrame: One year
measure: Cognitive function
timeFrame: One year
measure: Degree of Quality of life
timeFrame: One year
measure: Fecal microbiota
timeFrame: One year
measure: Degree Quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hospital Sant Pau
name: Germán Soriano, PhD
role: PRINCIPAL_INVESTIGATOR
References: