Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Chronic Liver Disease Clinical Trial

Official title:

A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04015570
• Other study ID #: ILBS-Cirrhosis-24
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Satyam Sinha, MD
• Phone: 01146300000
• Email: satyamsinhacmc5[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age-18-70 years

• Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

1. Grade IV DILI With T.B > 15

2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion Criteria:

• Evidence of active infection

• Refusal of consent or assent

• Patients with clinical suspicion of irreversible brain injury

• Pregnancy

• HCC (Hepatocellular Carcinoma) or any other malignancy

• Kidney failure

• Portal vein thrombosis

• Upper GastroIntestinal bleed

• Transplant

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Chronic Liver Disease
• Liver Diseases

Intervention

Biological:
• High Volume Plasma Exchange
PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity

Other:
• Standard Medical Treatment
Standard Medical Treatment (Albumin+High caloric diet)

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 both group		Day 28
Secondary	Number of participants with the development of organ dysfunction or failure in both group		Day 7
Secondary	Number of participants with the development of organ dysfunction or failure in both group		Day 15
Secondary	Number of participants with the development of organ dysfunction or failure in both group		Day 28