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Clinical Trials/CTRI/2024/03/063706
CTRI/2024/03/063706
Completed
Not Applicable

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 site in 1 country60 target enrollmentStarted: March 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Amar Minda
Enrollment
60
Locations
1
Primary Endpoint
To look for 28 day mortality, in hospital mortality and duration of ICU stay among various grades of CLIF C-ACLF

Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: at 48 hours and 28 days

Secondary Outcomes

  • not applicable(not applicable)

Investigators

Sponsor
Amar Minda
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Amar Minda

Kasturba Medical College Manipal

Study Sites (1)

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