跳至主要内容
临床试验/NCT07270809
NCT07270809招募中不适用

To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Death or liver transplant at 6 months follow up.

研究概览

简要总结

Title - To study the clinical course and outcomes of non-electively hospitalised patients of chronic liver disease (CLD) with Hepatic or Extra-hepatic predominant organ failure(s) at 6 months.

Summary - ACLF is a condition where acute insult leading to worsening liver failure with or without extra-hepatic failure leads to a high short-term mortality. However, the presence of cirrhosis, prior decompensation, non-hepatic/systemic acute insult, organ failure and treatment are different in different part of the world. This is due to in-homogenous patient cohort. The current study was planned for all patients of CLD, who were non-electively hospitalized and were followed up for long-term to identify the differences in clinical course, acute insult, organ failure, therapy and outcome in relation to liver failure with or without extra-hepatic organic failure. In the study the laboratory, clinical parameters, inflammatory and regenerative markers will be evaluated as a marker of disease progression, reversal, recompensation or regression. This will enable us to differentiate the ACLF between east and west, guide us for defining the natural course of CLD with failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-70 years
  • •CLD with or without cirrhosis with 1st or subsequent admissions for decompenasation and irrespective of any prior decompensation
  • •Non-electively hospitalized

排除标准

  • •Post-Liver transplant

研究组 & 干预措施

Chronic Liver Disease (CLD) With Hepatic Predominant Organ Failure

干预措施: No Intervention (Other)

Chronic Liver Disease (CLD) With Extra-hepatic Predominant Organ Failure

干预措施: No Intervention (Other)

结局指标

主要结局

Death or liver transplant at 6 months follow up.

时间窗: 6 months

次要结局

  • Recovery as per disease severity scores, i.e- decrease in MELD ≥5 and CTP ≥3(6 months)
  • Organ dysfunction and organ failures(day 28, day 90, day 180)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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