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).

Last updated: April 7, 2020
Sponsor: Institute of Liver and Biliary Sciences, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Liver Failure

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT03754400
ILBS-ACLF-02
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  1. Age >18 years to 65 years

  2. ACLF patients

Exclusion

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 volumeparacentesis),HRS(hepatorenal syndrome)

  1. Not given consent

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

  3. Pregnant/ HIV / HCC >2cm size

  4. Alcoholic hepatitis eligible for steroids

  5. Previous known allergic/adverse reaction to albumin

  6. Any clinical condition which the investigator considers would make the patientunsuitable for the trial

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

Study Design

Total Participants: 200
Study Start date:
September 10, 2018
Estimated Completion Date:
July 30, 2020

Connect with a study center

  • Institute of Liver & Biliary Sciences

    New Delhi, Delhi 110070
    India

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.