| 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
|
|
|
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
|
|
|
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 |