A study to determine if a new therapy(High Volume Plasma Exchange) can help in recovery of Acute on chronic Liver failure.

Phase 3

Not yet recruiting

• Conditions: Acute on Chronic Liver Failure

• Registration Number: CTRI/2017/12/010820
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Alcohol related Acute on Chronic Liver Failure (ACLF) is associated with high mortality. Presently the only definite therapy is Liver Transplantation.  These patients are sick and are at risk of developing infections which make them poor candidates for Liver Transplant. In order to improve the outcome in these patients, we plan to use high volume plasma (HVP) exchange. HVP has been shown to be beneficial in patients with Acute Liver Failure and also in ACLF (reported as case reports). In this Randomized control trial, we plan to treat one arm with HVP and standard therapy and the other arm with Standard therapy alone.  The result might be useful in changing the management protocol for ACLF.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-07-12
• Study Start: 2017-12-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Written informed consent.

• 18 years of age.

• ACLF grade 1 or 2.

Exclusion Criteria

• ACLF grade 3 2.
• Systolic blood pressure < 90 mm Hg 3.
• Lack of informed consent 4.
• Coexisting severe illness eg.
• coronary artery disease, malignancy etc 5.
• Post Liver Transplant patients 5.
• Pregnancy 6.
• Active infection- bacterial or fungal.
• Hepatocellular carcinoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF.	28 days

Secondary Outcome Measures

Name	Time	Method
To study the effect of HVP on CLIF-C ACLF score, APACHE II and SIRS.	To study the effect of HVP on resolution of organ failures in ACLF.

Trial Locations

Locations (1)

All India Institute of Medical sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical sciences

🇮🇳South, DELHI, India

Dr Shalimar

Principal investigator

9868397211

drshalimar@yahoo.com