NCT03754400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

November 17, 2018

Last Update Submit

April 7, 2020

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Transplant free survival in both groups

    28 days

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Albumin

EXPERIMENTAL

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: AlbuminOther: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

Antibiotics, nutrition and supportive treatment.

Other: Standard Medical Treatment

Interventions

AlbuminBIOLOGICAL

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.

Albumin
Standard Medical TreatmentOTHER

Antibiotics, nutrition and supportive treatment

AlbuminStandard Medical Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years to 65 years
  • ACLF patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Albumins

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Dr Rakesh Jagdish, MD

CONTACT

01146300000dr.rkj.kapil@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2018

First Posted

November 27, 2018

Study Start

September 10, 2018

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

IN(1)