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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
DMELD+
liver transplant recipients with a positive delta MELD
|
|
DMELD-
liver transplant recipients without delta MELD
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
overall mortality of LT recipients
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perioperative lenght of intensive care unit (ICU) stay
大体时间: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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
postoperative assessment of liver function
大体时间: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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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