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.

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.

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.

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