Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-03-27
Brief Title:
To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months-A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ACLF is defined differently in APASLEASL and AASLDAPASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLFThe definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice serum bilirubin 5 mgdL 85 micromolL and coagulopathy INR 15 or prothrombin activity 40 complicated within 4 weeks by clinical ascites andor encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver diseasecirrhosis and is associated with a high 28-day mortality From the point of view of intensivists events in form of organ dysfunction failure or mortality would cumulatively effect the outcomeReversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria as nearly all the patients included are after the index presentationWith mitigation of the acute insult and over time the hepatic reserve improves fibrosis regresses and the portal pressure decreases Further unlike patients with decompensated cirrhosis and similar to patients with ALF the reversal of coagulopathy preceded the reversal of jaundicethat is median time to reversal of syndrome ie jaundice and coagulopathy was 7 4-30days versus 19 7-60days for jaundice respectively The median time for reversal of syndrome ie jaundice and coagulopathy was 30 days Baseline albumin AARC score and Transient elastography predicted long term reversibility The disease severity assessment is needed for prognostication and to guide the therapy Furthermorethe available prediction scores have been validated at baselinebut none has been evaluated in a dynamic manner for prognostication in ACLF patientsA DYNAMIC Model that could predict the reversibility in ACLF is urgently required
Detailed Description:
HypothesisBaseline factors could reliably predict reversibility of ACLF will help in improved clinical outcomes and risk stratifications
Aim To identify the predictors based on clinical biochemical parameters and noninvasive tests to reliably predict reversibility of ACLF at 6 months
Methodology
Study population
Age - 18-75 years
Patients with ACLFas per APASL guidelines Study designProspective Cohort study done at Department of HepatologyInstitute of Liver and Biliary SciencesNew DelhiIndia The study will be conducted in Department of Hepatology
Duration2 year Sample size Assuming that the expected reversibility of ACLF of 60 and desired confidence interval CI of 95alpha-5 and precision-5we need to enroll 370 cases Considering 28-day mortality rate of around 30 in ACLF patients we intend to prospectively enroll around 480 patients during the study period
Monitoring and assessment All patients of ACLF with acute insult as mentioned in our inclusion criteria will be prospectively enrolled Patients will receive standard of care for ACLF During hospitalization patients will undergo investigations as per institutional protocol and will receive standard of care as per there acute insult
Once discharged all patients will be managed in out-patients as mentioned in the study timeline figure 1 and will undergo investigations as per the need for monitoring purpose The list of investigations are mentioned in the figure 2 and is the usual institutional standard of care for medical management of ACLF patients
Aim To identify the predictors based on clinical biochemical parameters and noninvasive tests to reliably predict reversibility of ACLF at 6 months
Methodology
Study population
Age - 18-75 years
Patients with ACLFas per APASL guidelines Study designProspective Cohort study done at Department of HepatologyInstitute of Liver and Biliary SciencesNew DelhiIndia The study will be conducted in Department of Hepatology
Duration2 year Sample size Assuming that the expected reversibility of ACLF of 60 and desired confidence interval CI of 95alpha-5 and precision-5we need to enroll 370 cases Considering 28-day mortality rate of around 30 in ACLF patients we intend to prospectively enroll around 480 patients during the study period
Monitoring and assessment All patients of ACLF with acute insult as mentioned in our inclusion criteria will be prospectively enrolled Patients will receive standard of care for ACLF During hospitalization patients will undergo investigations as per institutional protocol and will receive standard of care as per there acute insult
Once discharged all patients will be managed in out-patients as mentioned in the study timeline figure 1 and will undergo investigations as per the need for monitoring purpose The list of investigations are mentioned in the figure 2 and is the usual institutional standard of care for medical management of ACLF patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None