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
About this trial
This is an interventional treatment trial for Chronic Liver Disease
Eligibility Criteria
Inclusion Criteria:
- Age-18-70 years
Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)
- Grade IV DILI With T.B > 15
- 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
Sites / Locations
- Institute of Liver & Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
High Volume Plasma Exchange with SMT
Standard Medical Treatment
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. Standard Medical Treatment (Albumin + High Caloric Diet)
Standard Medical Treatment (Albumin + High Caloric Diet)