Clinical trial NCT03754400: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transplant free survival in both groups
timeFrame: 28 days
Secondary outcomes:
measure: Transplant free survival in both groups.
timeFrame: 7 days
measure: Incidence or resolution of infection in both groups
timeFrame: 7 day
measure: Incidence or resolution of infection in both groups
timeFrame: 14 day
measure: Incidence or resolution of infection in both groups
timeFrame: 28 day
measure: Number of participant with development of new organ failure in both groups.
timeFrame: 7 day
measure: Number of participant with development of new organ failure in both groups.
timeFrame: 14 day
measure: Number of participant with development of new organ failure in both groups.
timeFrame: 28 day
measure: Adverse events in both groups.
timeFrame: 28 day
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: