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Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation (POWER-LT)

24 de abril de 2026 actualizado por: Kalliopi Anna Poulia

Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial

This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Malnutrition and sarcopenia affect many patients awaiting liver transplantation and is associated with reduced quality of life and increased mortality. According to the current European Society for Clinical Nutrition and Metabolism (ESPEN) and European Association for the Study of the Liver (EASL) guidelines, a target of 1.2-1.5 g protein per kg body weight daily is recommended for patients with decompensated liver cirrhosis. While evidence supports that even protein distribution enhances muscle protein synthesis in healthy adults, specific protein timing recommendations are lacking for patients with end-stage liver disease.

Therefore, this randomized controlled trial aims to investigate the effects of a 12-week diet with even protein distribution plus exercise (Group A) versus skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C), primarily on nutritional status, body composition and functional status, and secondarily on anthropometric measurements, laboratory parameters, quality of life, disease severity, complications and mortality in liver transplant candidates. Moreover, late postoperative parameters, including length of hospital stay, length of intensive care unit stay, duration of mechanical ventilation, postoperative complications, hospital readmissions, reoperations and mortality will be examined for those who undergo transplantation.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kalliopi Anna Poulia
  • Número de teléfono: +30 2105294668
  • Correo electrónico: lpoulia@aua.gr

Copia de seguridad de contactos de estudio

  • Nombre: Evangelos Cholongitas
  • Número de teléfono: +30 2132061643
  • Correo electrónico: echolog@med.uoa.gr

Ubicaciones de estudio

  • Grecia
    • Attica
      • Athens, Attica, Grecia, 11855
        • Reclutamiento
        • Agricultural University of Athens
        • Contacto:
          • Kalliopi Anna Poulia
          • Número de teléfono: +30 2105294668
          • Correo electrónico: lpoulia@aua.gr
      • Athens, Attica, Grecia, 11527
        • Reclutamiento
        • Laiko General Hospital of Athens
        • Contacto:
          • Evangelos Cholongitas
          • Número de teléfono: +30 2132061643
          • Correo electrónico: echolog@med.uoa.gr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture
  • Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation
  • No prior formal dietary advice

Exclusion Criteria:

  • Age < 18 years old
  • Estimated waiting time for liver transplantation < 3 months
  • Estimated life expectancy < 3 months
  • Chronic kidney disease requiring protein restriction
  • Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)
  • Unstable or severe psychiatric disorder
  • Pregnancy or lactation
  • Inability to provide written informed consent

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Diet with even protein distribution plus exercise program
Conductual: Diet with even protein distribution plus exercise program
Diet of 1.2-1.5 g protein/kg dry body weight/day, equally divided (33.3% at 3 main meals) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks
Experimental: Diet with skewed protein distribution plus exercise program
Conductual: Diet with skewed protein distribution plus exercise program
Diet of 1.2-1.5 g protein/kg dry body weight/day, unequally divided (10.0% at breakfast, 60.0% at lunch, 30.0% at dinner) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks
Comparador activo: Standard dietary and physical activity advice
Conductual: Standard dietary and physical activity advice
Standard dietary and physical activity advice | Duration: 12 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition
Periodo de tiempo: Baseline, 12 weeks
Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria include: a. Non-votional weight loss (%): > 5% within past 6 months or > 10% beyond 6 months, b. Low body mass index (BMI, kg/m^2): < 20 kg/m^2 if < 70 years or < 22 kg/m^2 if > 70 years, c. Reduced muscle mass, assessed by validated body composition measuring techniques [e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT)]. Etiologic criteria include: a. Reduced food intake or assimillation: ≤ 50% of energy requirements > 1 week or any reduction for > 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption, b. Inflammation: acute disease/injury or chronic disease-related.
Baseline, 12 weeks
Changes in Computed Tomography (CT)-derived muscle mass
Periodo de tiempo: Baseline, 12 weeks
Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm^2/m^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m^2).Thresholds for reduced SMI will be considered < 50 cm^2/m^2 for men and < 39 cm^2/m^2 for women.
Baseline, 12 weeks
Changes in handgrip strength (kg)
Periodo de tiempo: Baseline, 12 weeks
Handgrip strength (kg) will be assessed using a digital handgrip dynamometer. Thresholds for reduced muscle strength will be considered < 27 kg for men and < 16 kg for women.
Baseline, 12 weeks
Changes in Short Physical Performance Battery (SPPB) score
Periodo de tiempo: Baseline, 12 weeks
The Short Physical Performance Battery (SPPB) includes 3 components: 3-positions balance testing (sec) (0-4 points), 4-meter gait speed test (sec) (0-4 points) and 5-times chair stand test (sec) (0-4 points), with a total score of 0-12. Higher scores indicate a better physical performance: 0-3 points for worst physical performance, 4-9 points for reduced physical performance and 10-12 points for best physical performance.
Baseline, 12 weeks
Changes in Liver Frailty Index
Periodo de tiempo: Baseline, 12 weeks
The Liver Frailty Index includes 3 components: handgrip strength (kg), 5-times chair stand test (sec) and 3-positions balance testing (sec). Higher scores indicate a greater degree of frailty.
Baseline, 12 weeks
Changes in European Working Group on Sarcopenia in Older People 2 (EWGSOP2)-derived sarcopenia
Periodo de tiempo: Baseline, 12 weeks
Sarcopenia will be diagnosed using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. Diagnosis requires low muscle strength and low muscle mass. Reduced muscle strength will be diagnozed by: a. Low handgrip strength (kg): > 27 kg for men and > 16 kg for women or b. Low chair stand test (sec): >15 sec for 5-times chair stand test. Reduced muscle mass will be diagnozed by: a. Low Appendicular Skeletal Muscle Mass (ASM, kg): < 20 kg for men and < 15 kg for women or b. Low Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2): <7.0 kg/m^2 for men and < 5.5 kg/m^2 for women.
Baseline, 12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Nutritional Risk Screening-2002 (NRS-2002) tool. Higher scores indicate greater nutritional risk: < 3 points indicate good nutritional status and ≥ 3 nutritional risk.
Baseline
Malnutrition Screening Tool (MST)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Malnutrition Screening Tool (MST) tool. Higher scores indicate greater nutritional risk: < 2 points indicate good nutritional status and ≥ 2 nutritional risk.
Baseline
Malnutrition Universal Screening Tool (MUST)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Malnutrition Universal Screening Tool (MUST) tool. Higher scores indicate greater nutritional risk: 0 points indicate low risk, 1 point medium risk and ≥ 2 high risk.
Baseline
Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Short Nutritional Assessment Questionnaire (SNAQ) tool. Higher scores indicate greater nutritional risk: 0-1 points indicate low risk, 2 points medium risk and ≥ 3 points high risk.
Baseline
Mini Nutritional Assessment-Short Form (MNA-SF)-derived nutritional status
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF) tool. Lower scores indicate greater nutritional risk: 12-14 points indicate good nutritional status, 8-11 points risk of malnutrition and 0-7 points malnutrition.
Baseline
Nutritional Risk Index (NRI)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Nutritional Risk Index (NRI) tool. Lower scores indicate greater nutritional risk: > 100.0 indicate good nutritional status, 97.5-100.0 low risk, 83.5-97.5 medium risk and < 83.5 high risk.
Baseline
Prognostic Nutritional Index (PNI)-derived nutritional status
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Prognostic Nutritional Index (PNI) tool. Lower scores indicate greater nutritional risk: ≥ 50 indicate good nutritional status, < 50 low risk, < 45 medium risk and < 40 high risk.
Baseline
Controlling Nutritional Status (CONUT)-derived nutritional status
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Controlling Nutritional Status (CONUT) tool. Higher scores indicate greater nutritional risk: 0-1 points indicate good nutritional status, 2-4 points low risk, 5-8 medium risk and 9-12 high risk.
Baseline
Liver Disease Undernutrition Screening Tool (LDUST)-derived nutritional risk
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Liver Disease Undernutrition Screening Tool (LDUST) tool. ≥ 5 answers "A" indicate good nutritional status and ≥ 2 answers "B" and/or "C" malnutrition.
Baseline
Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT)-derived nutritional status
Periodo de tiempo: Baseline
Nutritional risk will be assessed using the Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT) tool. Higher scores indicate greater nutritional risk: 0 points indicate low risk, 1 point medium risk and 2-7 points high risk.
Baseline
Dual-Energy X-ray Absorptiometry (DEXA)-derived muscle mass
Periodo de tiempo: Baseline
Muscle mass will be assessed using the Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2) using Dual-Energy X-ray Absorptiometry (DEXA). Thresholds for reduced muscle mass will be considered < 7.0 for men and < 5.4 for women.
Baseline
Food Frequency Questionnaire (FFQ)-derived dietary habits
Periodo de tiempo: Baseline
Long-term dietary habits will be assessed using a semi-quantitative Food Frequency Questionnaire (FFQ).
Baseline
International Physical Activity Questionnaire (IPAQ)-derived physical activity levels
Periodo de tiempo: Baseline
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ)-Short Form. IPAQ includes 7 open-ended questions. Higher scores (MET-min/week) indicate higher physical activity levels.
Baseline
Changes in Bioelectrical Impedance Analysis (BIA)-derived muscle mass
Periodo de tiempo: Baseline, 12 weeks
Muscle mass will be assessed using the Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2) by Bioelectrical Impedance Analysis (BIA). Thresholds for reduced ASMI will be considered < 7.0 for men and < 5.7 for women.
Baseline, 12 weeks
Changes in body weight (kg)
Periodo de tiempo: Baseline, 12 weeks
Body weight (kg) will be measured using a calibrated weight scale.
Baseline, 12 weeks
Changes in Body Mass Index (BMI, kg/m^2)
Periodo de tiempo: Baseline, 12 weeks
Body Mass Index (BMI, kg, m^2) will be calculated by dividing body weight (kg) by height squared (m^2), which will be measured using a calibrated stadiometer.
Baseline, 12 weeks
Changes in Mid-Arm Muscle Circumference (MAMC, cm)
Periodo de tiempo: Baseline, 12 weeks
Mid-Arm Muscle Circumference (MAMC, cm) will be calculated using the following formula: MAMC (cm) = Mid-Arm Circumference (MAC, cm) - [0.314*Triceps Skinfold Thickness (TSF, mm)]. MAC will be measured using a non-stretchable measuring tape and TSF using a calibrated skinfold caliper. Thresholds for reduced MAMC will be considered < 25 cm for men and < 22 cm for women.
Baseline, 12 weeks
Changes in Bristol Stool Chart
Periodo de tiempo: Baseline, 12 weeks
Bowel habits will be assessed using the Bristol Stool Chart. Bristol Stool Chart classifies stool forms in 7 types: types 1-2 indicate constipation, types 3-4 normal stool form, and types 5-7 looser stools tending toward diarrhea
Baseline, 12 weeks
Changes in Chronic Liver Disease Questionnaire (CLDQ)
Periodo de tiempo: Baseline, 12 weeks
Quality of life will be assessed using the Chronic Liver Disease Questionnaire (CLDQ). CLDQ includes 29 items in 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry. Each is scored on a 7-point scale, with higher domain and total scores indicating a better quality of life.
Baseline, 12 weeks
Changes in aspartate aminotransferase (AST, U/L)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in alanine aminotransferase (ALT, U/L)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review
Baseline, 12 weeks
Changes in alkaline phosphatase (ALP, U/L)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in gamma-glutamyltransferase (GGT, U/L)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in total bilirubin (mg/dL)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in direct bilirubin (mg/dL)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in International Normalized Ratio (INR)
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in MELD-Na score
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review. Higher MELD-Na scores indicate greater severity of chronic liver disease and higher predictive risk of mortality (< 17 points: <2%, 17-20 points: 3-4%, 21-22 points: 7-10%, 23-26 points: 14-15%, 27-31 points: 27-32%, ≥ 32 points: 65-66%)
Baseline, 12 weeks
Changes in Child-Pugh score
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review. Higher Child-Pugh scores indicate greater severity of liver cirrhosis [class A (5-6 points): mild, class B: (7-9 points): moderate, class C (10-15) points: severe]
Baseline, 12 weeks
Changes in presence of oedema and/or ascites
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of jaundice
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of variceal bleeding
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of infections
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of hepatic encephalopathy
Periodo de tiempo: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Mortality
Periodo de tiempo: From baseline to 12 weeks
Data will be collected through medical chart review.
From baseline to 12 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence to the program
Periodo de tiempo: 4 weeks, 8 weeks, 12 weeks
Adherence to the program will be assessed using 24-hour recalls and physical activity diaries.
4 weeks, 8 weeks, 12 weeks
Satisfaction with the program
Periodo de tiempo: 12 weeks
Satisfaction with the program will be assessed using a Likert scale: very satisfied, fairly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied and not at all satisfied
12 weeks
Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition
Periodo de tiempo: 3 months post-transplantation
Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria: a. Non-votional weight loss (%): > 5% within past 6 months or >10% beyond 6 months b. Low body mass index (BMI, kg/m^2): < 20 kg/m^2 if < 70 years or < 22 kg/m^2 if > 70 years c. Reduced muscle mass, assesses by validated body composition measuring techniques [e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT) Etiologic criteria: a. Reduced food intake or assimillation: ≤ 50% of energy requirements > 1 week or any reduction for > 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption b. Inflammation: acute disease/injury or chronic disease-related
3 months post-transplantation
Computed Tomography (CT)-derived muscle mass
Periodo de tiempo: 3 months post-transplantation
Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm^2/m^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m^2).Thresholds for reduced SMI will be considered < 50 cm^2/m^2 for men and < 39 cm^2/m^2 for women.
3 months post-transplantation
Handgrip strength (kg)
Periodo de tiempo: 3 months post-transplantation
Handgrip strength (kg) will be assessed using a digital handgrip dynamometer. Thresholds for reduced muscle strength will be considered < 27 kg for men and < 16 kg for women.
3 months post-transplantation
Short Physical Performance Battery (SPPB) score
Periodo de tiempo: 3 months post-transplantation
The Short Physical Performance Battery (SPPB) includes 3 components: 3-positions balance testing (sec) (0-4 points), 4-meter gait speed test (sec) (0-4 points) and 5-times chair stand test (sec) (0-4 points), with a total score of 0-12. Higher scores indicate a better physical performance: 0-3 points for worst physical performance, 4-9 points for reduced physical performance and 10-12 points for best physical performance.
3 months post-transplantation
Liver Frailty Index
Periodo de tiempo: 3 months post-transplantation
The Liver Frailty Index includes 3 components: handgrip strength (kg), 5-times chair stand test (sec) and 3-positions balance testing (sec). Higher scores indicate a greater degree of frailty.
3 months post-transplantation
European Working Group on Sarcopenia in Older People 2 (EWGSOP2)-derived sarcopenia
Periodo de tiempo: 3 months post-transplantation
Sarcopenia will be diagnosed using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) diagnostic criteria. Diagnosis requires the presence of low muscle strength and low muscle mass. Reduced muscle strength: a. Low handgrip strength (kg): > 27 kg for men and > 16 kg for women b. Low chair stand test (sec): >15 sec for 5 rises Reduced muscle mass: a. Low Appendicular Skeletal Muscle Mass (ASM, kg): < 20 kg for men and < 15 kg for women b. Low Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2): <7.0 kg/m^2 for men and < 5.5 kg/m^2 for women
3 months post-transplantation
Body weight (kg)
Periodo de tiempo: 3 months post-transplantation
Body weight (kg) will be measured using a calibrated weight scale.
3 months post-transplantation
Body Mass Index (BMI, kg, m^2)
Periodo de tiempo: 3 months post-transplantation
Body Mass Index (BMI, kg, m^2) will be calculated by dividing body weight (kg) by height squared (m^2), which will be measured using a calibrated stadiometer.
3 months post-transplantation
Mid-Arm Muscle Circumference (MAMC, cm)
Periodo de tiempo: 3 months post-transplantation
Mid-Arm Muscle Circumference (MAMC, cm) will be calculated using the following formula: MAMC (cm) = Mid-Arm Circumference (MAC, cm) - [0.314*Triceps Skinfold Thickness (TSF, mm)]. MAC will be measured using a non-stretchable measuring tape and TSF using a calibrated skinfold caliper. Thresholds for reduced MAMC will be considered < 25 cm for men and < 22 cm for women.
3 months post-transplantation
Bristol Stool Chart
Periodo de tiempo: 3 months post-transplantation
Bowel habits will be assessed using the Bristol Stool Chart. Bristol Stool Chart classifies stool forms in 7 types: types 1-2 indicate constipation, types 3-4 normal stool form, and types 5-7 looser stools tending toward diarrhea
3 months post-transplantation
Chronic Liver Disease Questionnaire (CLDQ)
Periodo de tiempo: 3 months post-transplantation
Quality of life will be assessed using the Chronic Liver Disease Questionnaire (CLDQ). CLDQ includes 29 items in 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry. Each is scored on a 7-point scale, with higher domain and total scores indicating a better quality of life.
3 months post-transplantation
Aspartate aminotransferase (AST, U/L)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Alanine aminotransferase (ALT, U/L)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Alkaline phosphatase (ALP, U/L)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Gamma-glutamyltransferase (GGT, U/L)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Total bilirubin (mg/dL)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Direct bilirubin (mg/dL)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
International Normalized Ratio (INR)
Periodo de tiempo: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Length of hospital stay
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Length of intensive care unit stay
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Duration of mechanical ventilation
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Postoperative complications
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Hospital readmissions
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Reoperations
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Mortality
Periodo de tiempo: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Kalliopi Anna Poulia

Colaboradores

Laikο General Hospital, Athens

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de enero de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

26 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 113/05.12.2025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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