NCT02467348

Brief Summary

All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on chronic Liver Failure). ACLF will be randomize into Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8 gms/L of ascitic fluid Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

November 28, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

June 4, 2015

Last Update Submit

November 25, 2017

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Total number of patients develop Circulatory Dysfunction because of paracentesis.

    1 Year

Secondary Outcomes (5)

  • Survival

    28 days

  • Total number of patients develop hepatorenal Syndrome.

    1 Year

  • Total number of patients develop hyponatremia.

    1 Year

  • Changes in aldosterone with volume of ascitic fluid tap

    1 Year

  • Changes in plasma renin activity

    1 year

Study Arms (2)

Albumin

EXPERIMENTAL

MVP (Modest Volume Paracentesis) of less than 5 litres with intravenous albumin at a dose 8 gms/l of ascitic fluid.

Drug: AlbuminDrug: Ascitic fluid

No Albumin

ACTIVE COMPARATOR

MVP (Modest Volume Paracentesis) of less than 5 litres without albumin.

Drug: Ascitic fluid

Interventions

AlbuminDRUG

Intravenous albumin 8 gms/L of ascitic fluid

Albumin
Ascitic fluidDRUG
AlbuminNo Albumin

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital.
  • All Cirrhotics decompensated with ascites admitted in the hospital.
  • Grade II/III ascites
  • Need for paracentesis.

You may not qualify if:

  • Age \<12 or \> 75 years
  • Hepatocellular carcinoma
  • Non cirrhotic ascites such as malignancy or tubercular peritonitis
  • Serum Cr \>1.5mg%
  • Refractory septic shock
  • Grade III/IV hepatic encephalopathy
  • Abdominal wall cellulitis
  • Active variceal bleed
  • Respiratory, cardiac and renal failure
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

Related Publications (1)

  • Arora V, Vijayaraghavan R, Maiwall R, Sahney A, Thomas SS, Ali R, Jain P, Kumar G, Sarin SK. Paracentesis-Induced Circulatory Dysfunction With Modest-Volume Paracentesis Is Partly Ameliorated by Albumin Infusion in Acute-on-Chronic Liver Failure. Hepatology. 2020 Sep;72(3):1043-1055. doi: 10.1002/hep.31071. Epub 2020 Jul 9.

    PMID: 31849085DERIVED

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

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

June 4, 2015

First Posted

June 10, 2015

Study Start

March 15, 2015

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

November 28, 2017

Record last verified: 2017-01

Locations

IN(1)