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Recruiting NCT07414095

Multidimensional Frailty Assessment and Post-Transplant Outcomes in Liver Transplant Candidates

— Observational End-Stage Liver Disease Liver Transplantation Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Observational Assessment in Liver Transplant Candidates.
Who it may be relevant to
Registry conditions: End-Stage Liver Disease, Liver Transplantation, Cirrhosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigation of the Relationship Between Frailty, Sarcopenia, Malnutrition, and Psychosocial Parameters and Post-Transplant Outcomes in Liver Transplant Candidates

Overview

This study will evaluate frailty, nutrition, sarcopenia, and psychological health in people waiting for a liver transplant. The purpose is to understand how these factors affect outcomes before and after transplantation. By identifying patients at higher risk early, the study aims to support the development of better care programs in the future. Participants will complete simple tests of physical strength, walking speed, and daily activity levels. Their nutrition and psychological well-being will also be assessed. The study will then look at how these results relate to medical scores used in liver disease and to outcomes after transplant, such as hospital stay, complications, or survival. Adults aged 18-65 years who are on the liver transplant waiting list and can understand Turkish are eligible to join.

Interventions

  • Other Comprehensive Observational Assessment in Liver Transplant Candidates
    This study involves a comprehensive, multidimensional assessment of liver transplant candidates focusing on frailty, sarcopenia, malnutrition, and psychosocial status. Frailty will be measured using the Liver Frailty Index (LFI), 6-Minute Walk Test (6MWT), Karnofsky Performance Status (KPS), and Activities of Daily Living (ADL). Sarcopenia will be evaluated through handgrip strength, Appendicular Skeletal Muscle Mass (ASM)/Skeletal Muscle Index (SMI), and 4-meter gait speed. Malnutrition will be

Primary outcome measures

  • Liver Frailty Index (LFI) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • 6-Minute Walk Test (6MWT) Distance [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Karnofsky Performance Status (KPS) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Activities of Daily Living (ADL) [Time frame: At hospital admission when liver transplantation is confirmed.]
Secondary outcome measures (12)
  • Nutritional Risk Index (NRI) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Phase Angle Measured by Bioelectrical Impedance Analysis (BIA) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Sarcopenia Diagnosis According to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) Criteria [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Handgrip Strength (HGS) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Skeletal Muscle Index (SMI) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Gait Speed (4-meter walk test) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Hospital Anxiety and Depression Scale - Total Score (HADS Total) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Charlson Comorbidity Index - Orthotopic Liver Transplant (CCI-OLT) [Time frame: At hospital admission when liver transplantation is confirmed.]
  • Intensive Care Unit (ICU) Length of Stay [Time frame: From the day of liver transplantation until ICU discharge (within 30 days post-transplant).]
  • Hospital Length of Stay [Time frame: From the day of liver transplantation until hospital discharge (within 30 days post-transplant).]

Eligibility criteria

Inclusion criteria

  • Being listed as a liver transplant candidate
  • Age between 18 and 65 years
  • Ability to understand the Turkish language

Exclusion criteria

  • Presence of orthopedic and/or neurological problems severe enough to prevent completion of assessment tools
  • Inability to understand verbal commands
  • Being a recipient of multiple organ transplants
  • Presence of serious active extrahepatic malignancy

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Izmir University of Economics Medical Point Hospital — Izmir

Identifiers

NCT: NCT07414095 · 2537

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗