High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure

Institute of Liver and Biliary Sciences, India40 enrolled

Overview

The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Liver Failure

Interventions

Plasma ExchangeBIOLOGICAL

Management of cerebral edema/intracranial hypertension:OTHER

Transfer to Intensive Care UnitOTHER

Prophylactic Antibiotics

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease. Exclusion Criteria: * Age \<12 or \> 75 years * Hepato-Cellular Carcinoma * Active untreated Sepsis/DIC * Any evidence of active bleed secondary to coagulopathy * Hemodynamic instability requiring high dose of Vasopressors * Coma of non-hepatic origin. * Pregnancy * Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease). * Patients being taken up for liver transplant * Refusal to participate in the study.

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Survival in both groups.

Time frame: 21 days

Secondary Outcomes

Duration of Intensive Care Unit stay in both groups.

Time frame: 21 days

Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

Time frame: 48 hours

Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

Time frame: day 5

Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.

Time frame: day 7

Improvement in SOFA (Sequential Organ Failure Assessment) score.

Time frame: 48 hours

Improvement in SOFA (Sequential Organ Failure Assessment) score.

Time frame: day 5

Improvement in SOFA (Sequential Organ Failure Assessment) score.

Time frame: day 7

Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.

Time frame: 48 hours

Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.

Time frame: Day 5

Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.

Time frame: Day 7

Data from ClinicalTrials.gov

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