Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed .

In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110070
        • Recruiting
        • Institute of Liver & Biliary Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients diagnosed with ACLF as per APASL criteria will be included.
  2. Age : 18-65 yrs.

Exclusion Criteria:

  1. Patient with ischemic heart disease
  2. Patient with chronic obstructive disease.
  3. Patient with hepato cellular carcinoma.
  4. Patient with extra hepatic malignancy.
  5. Patient with chronic renal insufficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Medical Treatment
Group A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
EXPERIMENTAL: Hemoadsorption plus standard medical therapy
Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Three sessions of Hemoperfusion, 1 plasma volume/session will be done to the selected patients.

Hemoperfusion will be done through bile acids and ammonia filters to adsorb bile acids and ammonia respectively.

Group specific fresh frozen plasma will be transfused to the patient through a peripheral vein catheter to prevent hypotension if required.

EXPERIMENTAL: Plasma Exchange plus standard medical therapy
Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Fresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved.

The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transplant free survival in all the group
Time Frame: day 28
day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of organ dysfunction in all the group
Time Frame: Day 7
Day 7
Development of organ dysfunction in all the group
Time Frame: Day 15
Day 15
Development of organ dysfunction in all the group
Time Frame: Day 28
Day 28
New onset of sepsis in ll the groups
Time Frame: Day 7
Day 7
New onset of sepsis in ll the groups
Time Frame: Day 15
Day 15
New onset of sepsis in ll the groups
Time Frame: Day 28
Day 28
Adverse Events in all the groups
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2019

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

July 31, 2020

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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