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

Primary Purpose

Acute-On-Chronic Liver Failure

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Haemoperfusion
Standard Medical Treatment
Plasma Exchange
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Medical Treatment

Hemoadsorption plus standard medical therapy

Plasma Exchange plus standard medical therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Transplant free survival in all the group

Secondary Outcome Measures

Development of organ dysfunction in all the group
Development of organ dysfunction in all the group
Development of organ dysfunction in all the group
New onset of sepsis in ll the groups
New onset of sepsis in ll the groups
New onset of sepsis in ll the groups
Adverse Events in all the groups

Full Information

First Posted
July 5, 2019
Last Updated
July 9, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04013113
Brief Title
Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hemoadsorption plus standard medical therapy
Arm Type
Experimental
Arm Title
Plasma Exchange plus standard medical therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Haemoperfusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard Medical Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plasma Exchange
Intervention Description
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).
Primary Outcome Measure Information:
Title
Transplant free survival in all the group
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Development of organ dysfunction in all the group
Time Frame
Day 7
Title
Development of organ dysfunction in all the group
Time Frame
Day 15
Title
Development of organ dysfunction in all the group
Time Frame
Day 28
Title
New onset of sepsis in ll the groups
Time Frame
Day 7
Title
New onset of sepsis in ll the groups
Time Frame
Day 15
Title
New onset of sepsis in ll the groups
Time Frame
Day 28
Title
Adverse Events in all the groups
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with ACLF as per APASL criteria will be included. Age : 18-65 yrs. Exclusion Criteria: Patient with ischemic heart disease Patient with chronic obstructive disease. Patient with hepato cellular carcinoma. Patient with extra hepatic malignancy. Patient with chronic renal insufficiency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Vinay Kumar, MD
Phone
01146300000
Email
drvinaybr@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vinay Kumar, MD
Phone
01146300000
Email
drvinaybr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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