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).

Not Applicable

• Conditions: Acute on Chronic Liver Failure
• Interventions: Biological: Albumin; Other: Standard Medical Treatment

• Registration Number: NCT03754400
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-24
• Study First Posted: 2018-11-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age >18 years to 65 years
2. ACLF patients

Exclusion Criteria

1. Patients who have already received albumin in last 1 week

2. Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)

   ,SBP (Spontaneous bacterial peritonitis),LVP(large volume paracentesis),HRS(hepatorenal syndrome)

3. Not given consent

4. Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses) /volume overload /upper GI bleed.

5. Pregnant/ HIV / HCC >2cm size

6. Alcoholic hepatitis eligible for steroids

7. Previous known allergic/adverse reaction to albumin

8. Any clinical condition which the investigator considers would make the patient unsuitable for the trial

9. Patients who will receive palliative treatment only during their hospital admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin	Standard Medical Treatment	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.
Standard Medical Treatment	Standard Medical Treatment	Antibiotics, nutrition and supportive treatment.
Albumin	Albumin	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.

Primary Outcome Measures

Name	Time	Method
Transplant free survival in both groups	28 days

Secondary Outcome Measures

Name	Time	Method
Transplant free survival in both groups.	7 days
Incidence or resolution of infection in both groups	28 day
Number of participant with development of new organ failure in both groups.	28 day
Adverse events in both groups.	28 day

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India