Back to resultsEfficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
Primary Purpose
Acute on Chronic Liver Failure
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Albumin
Standard Medical Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute on Chronic Liver Failure
Eligibility Criteria
Inclusion Criteria:
- Age >18 years to 65 years
- ACLF patients
Exclusion Criteria:
- Patients who have already received albumin in last 1 week
Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
- Not given consent
- Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
- Pregnant/ HIV / HCC >2cm size
- Alcoholic hepatitis eligible for steroids
- Previous known allergic/adverse reaction to albumin
- Any clinical condition which the investigator considers would make the patient unsuitable for the trial
- Patients who will receive palliative treatment only during their hospital admission
Sites / Locations
- Institute of Liver & Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Albumin
Standard Medical Treatment
Arm Description
All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
Antibiotics, nutrition and supportive treatment.
Outcomes
Primary Outcome Measures
Transplant free survival in both groups
Secondary Outcome Measures
Transplant free survival in both groups.
Incidence or resolution of infection in both groups
Incidence or resolution of infection in both groups
Incidence or resolution of infection in both groups
Number of participant with development of new organ failure in both groups.
Number of participant with development of new organ failure in both groups.
Number of participant with development of new organ failure in both groups.
Adverse events in both groups.
Full Information
NCT ID
NCT03754400
First Posted
November 17, 2018
Last Updated
April 7, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03754400
Brief Title
Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
Official Title
A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The AIM of the study is to study the efficacy of intravenous albumin and standard medical treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and improving survival at 28 days .The project will be conducted in ILBS from august 2018 to December 2019Concept is to understand the immunology, pathophysiology and effects of albumin in the management of ACLF for betterment of the patient's condition and early recovery.
All ACLF patients will be included as per the inclusion and exclusion criteria , after taking informed consent from the patient or their relatives. Will be evaluated for the possible risk factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per this protocol versus standard medical treatment alone will be reviewed If patient develops allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be treated accordingly to medical condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Albumin
Arm Type
Experimental
Arm Description
All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
Antibiotics, nutrition and supportive treatment.
Intervention Type
Biological
Intervention Name(s)
Albumin
Intervention Description
All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
Intervention Type
Other
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Antibiotics, nutrition and supportive treatment
Primary Outcome Measure Information:
Title
Transplant free survival in both groups
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Transplant free survival in both groups.
Time Frame
7 days
Title
Incidence or resolution of infection in both groups
Time Frame
7 day
Title
Incidence or resolution of infection in both groups
Time Frame
14 day
Title
Incidence or resolution of infection in both groups
Time Frame
28 day
Title
Number of participant with development of new organ failure in both groups.
Time Frame
7 day
Title
Number of participant with development of new organ failure in both groups.
Time Frame
14 day
Title
Number of participant with development of new organ failure in both groups.
Time Frame
28 day
Title
Adverse events in both groups.
Time Frame
28 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years to 65 years
ACLF patients
Exclusion Criteria:
Patients who have already received albumin in last 1 week
Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)
,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)
Not given consent
Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.
Pregnant/ HIV / HCC >2cm size
Alcoholic hepatitis eligible for steroids
Previous known allergic/adverse reaction to albumin
Any clinical condition which the investigator considers would make the patient unsuitable for the trial
Patients who will receive palliative treatment only during their hospital admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Rakesh Jagdish, MD
Phone
01146300000
Email
dr.rkj.kapil@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).
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