| CTRI Number |
CTRI/2024/10/075488 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study efficacy and safety of low dose albumin infusion in patients of decompensated cirrhosis with Acute Kidney Injury |
|
Scientific Title of Study
|
Efficacy and safety of recommended dose of albumin infusion vs. low dose albumin infusion in patients of decompensated cirrhosis with Acute Kidney Injury |
| 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 Aman Agrawal |
| 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
DELHI
110002
India |
| Phone |
9602166504 |
| Fax |
|
| Email |
amanagrawal.sms96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| 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
DELHI
110002
India |
| Phone |
9718599226 |
| Fax |
|
| Email |
ajaykumar.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| 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
Betul
DELHI
110002
India |
| Phone |
9718599226 |
| Fax |
|
| Email |
ajaykumar.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Postgraduate Medical Education And Research, Jawahar Lal Nehru Marg, New Delhi, Delhi, India. 110002 |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute of Postgraduate Medical Education And Research |
| Address |
Jawahar Lal Nehru Marg New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Aman Agrawal |
Govind Ballabh Pant Institute of Postgraduate Medical Education And Research |
Academic Block Second Floor, Department of Gastroenterology,
Govind Ballabh Pant Institute of Post Graduate Medical Education
and Research, Jawahar Lal Nehru Marg
New Delhi
DELHI |
9602166504
amanagrawal.sms96@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
20% human Albumin infusion at a dose of 1gm/ kg body weight per day (maximum daily dose 100gm) for 2 days |
| Intervention |
Intervention |
20% human Albumin infusion at a dose of 0.5 gm/ kg body weight per day (maximum daily dose 100gm) for 2 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of decompensated cirrhosis with Acute kidney injury ≥Stage IB i.e. Serum
creatinine ≥1.5mg/dl |
|
| ExclusionCriteria |
| Details |
Pregnancy
Advanced Chronic Kidney Disease
Shock
Prior Kidney or Liver Transplant
Acute or chronic Renal Replacement Therapy at the time of enrolment
Congestive heart failure
ï‚· Known allergy or develops allergic reaction to human albumin |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of decompensated cirrhosis patients having acute kidney injury with complete resolution
(S. Cr. within 0.3mg/dl of Baseline S. Creatinine) of acute kidney injury after 2 consecutive days of fluid
challenge with 20% human albumin at a dose of –
1gm/kg of body weight daily;
0.5gm/kg of body weight daily |
After 2 consecutive days of fluid challenge with 20% human albumin at a dose of –
1gm/kg of body weight daily
0.5gm/kg of body weight daily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency of adverse events among patients treated with 20% human albumin at a dose of-
1gm/kg of body weight daily;
0.5gm/kg of body weight daily |
during hospital stay |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - amanagrawal.sms96@gmail.com
- For how long will this data be available start date provided 01-01-2026 and end date provided 04-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ours is a Open labelled Randomized controlled trial in which we aim to compare the efficacy and safety of 20% human albumin infusion at a dose of 1gm/kg body weight daily (maximum dose 100gm) with albumin infusion at a dose of 0.5 gm/kg body weight (maximum dose 40gm) in patients with decompensated cirrhosis having acute kidney injury. |