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 Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Acute on Chronic Liver Failure

Intervention / Treatment
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* Biological: Albumin
* Other: Standard Medical Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin<br>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. | Biological: Albumin<br>* 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.<br>Other: Standard Medical Treatment<br>* Antibiotics, nutrition and supportive treatment<br>|
| Active Comparator: Standard Medical Treatment<br>Antibiotics, nutrition and supportive treatment. | Other: Standard Medical Treatment<br>* Antibiotics, nutrition and supportive treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |