Role of High Volume Plasma Exchange in Acute on chronic Liver failure: A Pilot Randomized Control Trial.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent.
- •> 18 years of age.
- •ACLF grade 1 or 2.
Exclusion Criteria
- •ACLF grade 3
- •Systolic blood pressure < 90 mm Hg
- •Lack of informed consent
- •Coexisting severe illness eg.
- •coronary artery disease, malignancy etc
- •Post Liver Transplant patients
- •Pregnancy
- •Active infection- bacterial or fungal.
- •Hepatocellular carcinoma.
Outcomes
Primary Outcomes
To study the effect of high volume plasma (HVP) exchange on 28 day mortality in patients with alcohol-related ACLF.
Time Frame: 28 days
Secondary Outcomes
- 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.)