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CTRI Number  CTRI/2024/05/068102 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To check the natural history and prognosis in patients with acute on chronic liver failure  
Scientific Title of Study   To Study the Natural History and Prognosis of Patients with Acute- On-Chronic Liver Failure [ACLF): A Multicentric Prospective Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shiran Shetty 
Designation  Professor and Head of Unit 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  drshiran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shiran Shetty 
Designation  Professor and Head of Unit 
Affiliation  Manipal Academy of Higher Education  
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861920517  
Fax    
Email  drshiran@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaji Musunuri 
Designation  Associate Professor  
Affiliation  Manipal Academy of Higher Education 
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9040581639  
Fax    
Email  balajimbmc@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Balaji Musunuri  Kasturba Medical College  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
9448001305

balajimbmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients with acute hepatic insult manifesting as jaundice (Sr. Bi l. 5 mg/dL) and coagulopathy (INR
1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously
diagnosed or undiagnosed chronic liver disease.
 
 
ExclusionCriteria 
Details  Age less than 18 and more than 75 years
HCC or Extra-hepatic malignancy
Pregnancy
Patients being taken up for transplant
Refusal to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the acute and chronic insult which have impact on outcomes of ACLF  Day 0, Day 4, Day 7, Day 30, Day 180 and Day 365  
 
Secondary Outcome  
Outcome  TimePoints 
To study the acute and chronic insults which have an impact on outcome of ACLF
To study whether sepsis is a cause or effect of ACLF and define the Golden therapeutic window
To study organ failure in ACLF ( Kidney/ Brain/ Coagulation/ Variceal bleed)
To study the liver transplant criteria for ACLF
To validate new prognost ic model and liver failure grading in ACLF
 
Day 0, Day 4, Day 7, Day 30, Day 180 and Day 365  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Upon receiving the consent from the patient, Following data is to be collected as follows:

Clinical history and examination

Mode of decompensation

Etiology of acute event

Etiology of chronic event

Severity assessment indices

Complications if any

Investigations

Hematology

CBC, Prothrombin time and INR, Peripheral smear, Reties Biochemistry

Liver function testing, AFP 

Kidney function test

Etiology of acute event:

Infectious etiology: IgM anti HAY , lgM anti HEY, lgM anti HBc ( If HBsAg +ve), lgM anti HDY ( If HBsAg +ve), HEY RNA

Non Infectious etiology: Alcohol binging in last 4 weeks, hepatotoxic drugs, ANA (> 1: 80), lgG, surgeries in past 4 weeks. acute variceal bleed within 4 weeks

Etiology of underlying chronic liver disease :

Infectious etiology: total anti HBc, anti HCY, HCY RNA, HBY DNA

Non infectious etiology: Autoimmune markers, copper studies, iron studies.

HOMA IR, FBS

Ascitic fluid analysis

UGI endoscopy and liver biopsy as needed

Any other investigations as per clinical need and judgement of physician

Imaging
USG abdomen with Doppler for spleno-portal axis OR CECT- Triple phase upper abdomen

Follow-up
Treatment will be done as per treating physician
Physical examination will be done daily, after I week and at 4 weeks, at 2 months, at 3 months and at 6 months
CBC on alternate day for 1 week, at end of I week and then at end of 4 weeks at 2 months, at 3 months and at 6 months
KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months, at 3 months and at 6 months
 
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