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临床试验/NCT07570901
NCT07570901已完成不适用

Delta MELD as a Predictor of Decreased Survival in High MELD Liver Transplant Recipients

University of Jena2 个研究点 分布在 2 个国家目标入组 446 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
446
试验地点
2
主要终点
overall mortality of LT recipients

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age above 18 years
  • completeness of dataset
  • liver only

排除标准

  • second or higher LT
  • age below 18 years
  • incomplete dataset
  • combined transplant

研究组 & 干预措施

DMELD+

liver transplant recipients with a positive delta MELD

DMELD-

liver transplant recipients without delta MELD

结局指标

主要结局

overall mortality of LT recipients

时间窗: minimal follow up of 12 months up to fifteen years

overall mortality of liver transplant recipients

次要结局

  • Perioperative lenght of intensive care unit (ICU) stay(perioperative ICU stay, measured in days following liver transplantation maximal 24 weeks)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Sariye Pollmann

Principal Investigator

University of Jena

研究点 (2)

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