Impact of Delta Model of End Stage Liver Disease (MELD) in High MELD Liver Transplant Recipients (HDMELD in LT)
Delta MELD as a Predictor of Decreased Survival in High MELD Liver Transplant Recipients
Liver transplantation (LT) represents an important curative option for end stage liver disease such as decompensated cirrhosis, which remains a major challenge for today's health care system. The Model for End-Stage Liver Disease (MELD) is a worldwide-established scoring system for the evaluation of the severity of liver disease in allocation processes. However, the interpretation of MELD in clinical practice, particularly with regard to prioritizing potential liver transplant recipients, has revealed some hazards. These include the adaptation of MELD based on patient's characteristics, e.g. the presence of hepatocellular carcinoma, kidney failure and cardiovascular disease. In addition, the remaining paucity of organ donors contributes to a rising number of transplantations of high MELD recipients. This leads to the risk of impaired outcomes, especially considering the interaction of additional donor and recipient risk factors, such as extended cold preservation, kidney function and warm ischemia. For a certain patient cohort living donation might represent a feasible approach as reported previously for high MELD patients.
Overall, the interaction of donor and recipient characteristics on the outcomes after LT in high MELD patients remains a scarcely investigated field. Therefore, the identification of factors influencing patient's outcomes after orthotopic liver transplantation becomes increasingly important, especially in high MELD recipients.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
The underlying study aims to investigate several questions. The sodium corrected MELD score is the cornerstone of liver allocation, prioritizing patients with the highest short-term mortality risk. However, outcomes after transplantation among recipients with very high MELD scores remain heterogeneous. While some critically ill patients recover and achieve favorable long-term survival, others experience early post-transplant mortality, raising concerns about futile transplantation in a subset of high-risk candidates.
Current allocation systems rely on a static MELD value at the time of transplantation, which may not fully capture the dynamic trajectory of liver disease, the relative contribution of individual MELD components, or the interaction between recipient severity and donor graft characteristics. Improved risk stratification within the high MELD population is therefore needed to better balance urgency and utility in liver allocation.
Primary Objective
To determine whether changes in MELD score (delta MELD) prior to transplantation are predictive of post-transplant survival in high MELD recipients.
Secondary Objectives
To identify clinical and biochemical characteristics associated with futile liver transplantation, defined as early post-transplant mortality among recipients with very high MELD scores.
To evaluate whether exceeding a MELD threshold of 30 is independently associated with poor post-transplant outcomes.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- first LT
- age above 18 years
- completeness of dataset
- liver only
Exclusion Criteria:
- second or higher LT
- age below 18 years
- incomplete dataset
- combined transplant
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
DMELD+
liver transplant recipients with a positive delta MELD
|
|
DMELD-
liver transplant recipients without delta MELD
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
overall mortality of LT recipients
Tijdsspanne: minimal follow up of 12 months up to fifteen years
|
overall mortality of liver transplant recipients
|
minimal follow up of 12 months up to fifteen years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Perioperative lenght of intensive care unit (ICU) stay
Tijdsspanne: perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
|
Perioperative length of intensive care unit treatment in days,
|
perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
postoperative assessment of liver function
Tijdsspanne: laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months
|
postopertative liver function measured by laboratory values
|
laboratory values at routine follow-up appointments within 1 year following LT; usually at one, three, six and twelve months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026_07_02
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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