Effectiveness of Plasma Exchange in Acute on Chronic Liver Failure(Liver Disease).

Recruiting

• Conditions: Liver disease, unspecified,

• Registration Number: CTRI/2019/07/020247
• Lead Sponsor: Institute of Liver and Biliary Sciences

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-20
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant free survival in all the group	Day 28

Secondary Outcome Measures

Name	Time	Method
Development of organ dysfunction in all the group	Day 7,15 and 28
New onset of sepsis in ll the groups	Day 7,15 and 28
Adverse Events in all groups	Day 28

Trial Locations

Locations (1)

Institute of Liver and Biliary Science; 🇮🇳 South, DELHI, India

Institute of Liver and Biliary Science

🇮🇳South, DELHI, India

Dr Vinay Kumar

Principal investigator

01146300000

drvinaybr@gmail.com