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临床试验/CTRI/2024/03/063706
CTRI/2024/03/063706已完成不适用

Clinical Profile of Acute on Chronic Liver Failure and Chronic Liver Failure Consortium Acute on Chronic Liver Failure (CLIF C ACLF) score as a predictor of its short-term mortality

Amar Minda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To look for 28 day mortality, in hospital mortality and duration of ICU stay among various grades of CLIF C-ACLF

研究概览

简要总结

NEED FOR THE STUDY

It is very important to stratify patients according to prognosis, monitor treatment responsiveness, determine emergency for transplantation, decide allocation in the intensive care unit (ICU), and have a rational basis to decide futility. Despite this catastrophic presentation and outcome, there is a component of potential reversibility with adequate support and management of the precipitating factor. Although several lines of evidence demonstrate that CLIF C ACLF prognostic score is superior to the conventional prognostic scores for the estimation of prognosis in these patients, the optimum score with the highest performance has not been enough explored yet, especially in India. A universally accepted prognostic model for ACLF is lacking due to discrepancies and unevenness in the definition of ACLF.

DESCRIPTION

Patients will be selected based on the above criteria and recruited into the study after taking informed written consent, confidentiality will be maintained. Demographic and clinical data of every patient with ACLF including age, gender, and BMI will be recorded in a data Proforma. Laboratory data including complete blood count, renal function and liver function tests, coagulation profile, and arterial blood gas analysis done at 48 hours of admission will be documented. CLIF C ACLF score will be calculated and patients will be categorized into various grades of CLIF C ACLF. Clinical outcomes will be assessed by: 1) 28-day mortality, 2) in-hospital mortality, and 3) duration of ICU/ HDU stay among various grades of CLIF C AClF. As this study is purely observational, patient management and antimicrobial therapy will be chosen by patients’ physicians without any intervention from study investigators.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients of both genders aged more than 18 years with the diagnosis of ACLF according to the EASL CLIF definition.

排除标准

  • Previously diagnosed Hepatocellular carcinoma
  • Have severe chronic extrahepatic disease
  • Retro positive
  • Patient on immunosuppressive drugs
  • Acute CVA
  • Orthotopic liver transplantation during follow- up
  • Pregnant females
  • Those who are not willing to participate in the study.

结局指标

主要结局

To look for 28 day mortality, in hospital mortality and duration of ICU stay among various grades of CLIF C-ACLF

时间窗: at 48 hours and 28 days

次要结局

  • not applicable(not applicable)

研究者

发起方
Amar Minda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Amar Minda

Kasturba Medical College Manipal

研究点 (1)

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