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

24. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Kalliopi Anna Poulia
  • Telefonnummer: +30 2105294668
  • E-Mail: lpoulia@aua.gr

Studieren Sie die Kontaktsicherung

Studienorte

  • Griechenland
    • Attica
      • Athens, Attica, Griechenland, 11855
        • Rekrutierung
        • Agricultural University of Athens
        • Kontakt:
          • Kalliopi Anna Poulia
          • Telefonnummer: +30 2105294668
          • E-Mail: lpoulia@aua.gr
      • Athens, Attica, Griechenland, 11527
        • Rekrutierung
        • Laiko General Hospital of Athens
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Diet with even protein distribution plus exercise program
Verhalten: 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
Verhalten: 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
Aktiver Komparator: Standard dietary and physical activity advice
Verhalten: Standard dietary and physical activity advice
Standard dietary and physical activity advice | Duration: 12 weeks

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in alanine aminotransferase (ALT, U/L)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review
Baseline, 12 weeks
Changes in alkaline phosphatase (ALP, U/L)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in gamma-glutamyltransferase (GGT, U/L)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in total bilirubin (mg/dL)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in direct bilirubin (mg/dL)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in International Normalized Ratio (INR)
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in MELD-Na score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of jaundice
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of variceal bleeding
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of infections
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Changes in presence of hepatic encephalopathy
Zeitfenster: Baseline, 12 weeks
Data will be collected through medical chart review.
Baseline, 12 weeks
Mortality
Zeitfenster: From baseline to 12 weeks
Data will be collected through medical chart review.
From baseline to 12 weeks

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence to the program
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Alanine aminotransferase (ALT, U/L)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Alkaline phosphatase (ALP, U/L)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Gamma-glutamyltransferase (GGT, U/L)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Total bilirubin (mg/dL)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Direct bilirubin (mg/dL)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
International Normalized Ratio (INR)
Zeitfenster: 3 months post-transplantation
Data will be collected through medical chart review.
3 months post-transplantation
Length of hospital stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Postoperative complications
Zeitfenster: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Hospital readmissions
Zeitfenster: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Reoperations
Zeitfenster: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation
Mortality
Zeitfenster: From transplantation to 3 months post-transplantation
Data will be collected through medical chart review.
From transplantation to 3 months post-transplantation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kalliopi Anna Poulia

Mitarbeiter

Laikο General Hospital, Athens

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Januar 2026

Primärer Abschluss (Geschätzt)

1. Juli 2028

Studienabschluss (Geschätzt)

1. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

26. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 113/05.12.2025

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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