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).

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).

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.

Study Overview

• Status: Unknown
• Conditions: Acute on Chronic Liver Failure
• Intervention / Treatment: Other: Standard Medical Treatment; Biological: Albumin

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Standard Medical Treatment; Antibiotics, nutrition and supportive treatment; Biological: 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.
Active Comparator: Standard Medical Treatment; Antibiotics, nutrition and supportive treatment.	Other: Standard Medical Treatment; Antibiotics, nutrition and supportive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transplant free survival in both groups	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Transplant free survival in both groups.	7 days
Incidence or resolution of infection in both groups	7 day
Incidence or resolution of infection in both groups	14 day
Incidence or resolution of infection in both groups	28 day
Number of participant with development of new organ failure in both groups.	7 day
Number of participant with development of new organ failure in both groups.	14 day
Number of participant with development of new organ failure in both groups.	28 day
Adverse events in both groups.	28 day

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: November 24, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: ILBS-ACLF-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No