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

Acute-On-Chronic Liver Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013113
• Other study ID #: ILBS-ACLF-03
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Vinay Kumar, MD
• Phone: 01146300000
• Email: drvinaybr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Haemoperfusion
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.
• Standard Medical Treatment
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.

Other:
• Plasma Exchange
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).

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 all the group		day 28
Secondary	Development of organ dysfunction in all the group		Day 7
Secondary	Development of organ dysfunction in all the group		Day 15
Secondary	Development of organ dysfunction in all the group		Day 28
Secondary	New onset of sepsis in ll the groups		Day 7
Secondary	New onset of sepsis in ll the groups		Day 15
Secondary	New onset of sepsis in ll the groups		Day 28
Secondary	Adverse Events in all the groups		Day 28