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Идёт набор NCT07414095

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

— Наблюдательное End-Stage Liver Disease Liver Transplantation Cirrhosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Comprehensive Observational Assessment in Liver Transplant Candidates.
Кому может быть актуально
Состояния в реестре: End-Stage Liver Disease, Liver Transplantation, Cirrhosis. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

NCT: NCT07414095 · 2537

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗