CTRI

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CTRI Number

CTRI/2024/02/062896 [Registered on: 20/02/2024] Trial Registered Prospectively

Last Modified On:

11/02/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Other

Public Title of Study

It is study on what happens to patients with liver disease who are hospitalized because their condition suddenly worsens.

Scientific Title of Study

Study of clinical outcome of cirrhotic patients admitted with an episode of acute decompensation

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 KAPIL KUMAR
Designation	Senior Resident
Affiliation	Delhi university
Address	Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg New Delhi New Delhi DELHI 110002 India
Phone	9891680438
Fax
Email	kapil8010@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ujjwal Sonika
Designation	Senior Resident
Affiliation	Associate Professor
Address	Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg New Delhi New Delhi DELHI 110002 India
Phone	9891680438
Fax
Email	usonika@gmail.com

Details of Contact Person
Public Query

Name	Dr KAPIL KUMAR
Designation	Senior Resident
Affiliation	Delhi University
Address	Academic Block Second Floor, Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research , Jawahar Lal Nehru Marg New Delhi New Delhi DELHI 110002 India
Phone	9891680438
Fax
Email	kapil8010@gmail.com

Source of Monetary or Material Support

Department of Gastroenterology , Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, Jawahar Lal Nehru Marg New Delhi DELHI 110002 India

Primary Sponsor

Name	Govind Ballabh Pant Institute of Post Graduate Medical Education and Research
Address	Jawahar Lal Nehru Marg New Delhi DELHI-110002
Type of Sponsor	Government medical college

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 Kapil Kumar	Govind Ballabh Pant Institute of Post Graduate Medical Education and Research	Department of Gastroenterology, Academic Block Second Floor, New Delhi DELHI	9891680438 kapil8010@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Maulana Azad Medical college and Associated 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: K74\|\|Fibrosis and cirrhosis of liver,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Diagnosed cases of chronic liver disease presenting with acute Decompensation with or without prior Decompensation

ExclusionCriteria

Details

1. Acquired or inherited immunodeficiency
2. Prior liver transplant
3. On any immunosuppressive therapy
4. Acute on chronic liver failure
5. Confirmed pregnancy
6. Patient with life-threatening chronic condition like uncontrolled diabetes mellitus, acute Decompensated heart failure, end stage renal disease, severe COPD.
7. Diagnosed case of Hepatocellular carcinoma
8. Extra-hepatic malignancy

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The proportion of Pre-ACLF, UDC (unstable decompensated cirrhotic), SDC (stable decompensated cirrhotic) in cirrhotic patients who are admitted with an episode of Acute decompensation.	Patients will be followed at following intervals - At admission, At 2 weeks, At 1 month, At 2nd month, At 3rd month

Secondary Outcome

Outcome	TimePoints
The clinical & biochemical predictors of mortality & development of ACLF during the follow-up period. The clinical & biochemical predictors of development of stable decompensated cirrhotic during the follow-up period.	Patients will be followed at following intervals - At admission, At 2 weeks, At 1 month, At 2nd month, At 3rd month

Target Sample Size

Total Sample Size="105"
Sample Size from India="105"
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)

01/03/2024

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

I will be doing observational study in cirrhotic patients of any etiology who are admitted with acute decompensation and will follow up those patients till 3 months by biochemical markers. So that we can predict the patients, that are going to have ACLF or Unstable Decompensated cirrhosis or Stable decompensated Cirrhosis on follow up, So we can treat them accordingly at their acute decompensation.