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).

Acute on Chronic Liver Failure Clinical 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754400
• Other study ID #: ILBS-ACLF-02
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Rakesh Jagdish, MD
• Phone: 01146300000
• Email: dr.rkj.kapil[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Intervention

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.

Other:
• Standard Medical Treatment
Antibiotics, nutrition and supportive treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival in both groups		28 days
Secondary	Transplant free survival in both groups.		7 days
Secondary	Incidence or resolution of infection in both groups		7 day
Secondary	Incidence or resolution of infection in both groups		14 day
Secondary	Incidence or resolution of infection in both groups		28 day
Secondary	Number of participant with development of new organ failure in both groups.		7 day
Secondary	Number of participant with development of new organ failure in both groups.		14 day
Secondary	Number of participant with development of new organ failure in both groups.		28 day
Secondary	Adverse events in both groups.		28 day