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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute Liver Failure

Treatments: Other: Volume Replacement; Drug: Prophylactic Antibiotics; Other: Management of cerebral edema/intracranial hypertension:; Other: Pressor Support; Other: Correction of metabolic parameters; Other: Intubation of trachea; Dietary Supplement: Correction of nutrition; Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure; Biological: Plasma Exchange; Drug: N-acetyl-L-cysteine; Other: Transfer to Intensive Care Unit

Study type: Interventional

Funder types: Other

Identifiers

NCT02718079

ILBS-ALF-03

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard medical therapy with Plasma Exchange

Experimental group

Description:

Plasma Exchange will be performed for consecutive days. Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition.

Treatment:

Drug: Prophylactic Antibiotics

Other: Transfer to Intensive Care Unit

Biological: Plasma Exchange

Dietary Supplement: Correction of nutrition

Other: Correction of metabolic parameters

Drug: N-acetyl-L-cysteine

Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure

Other: Intubation of trachea

Other: Management of cerebral edema/intracranial hypertension:

Other: Pressor Support

Other: Volume Replacement

Standard medical therapy alone

Active Comparator group

Description:

Standard medical therapy included as per requirement,management of cerebral edema/intracranial hypertension: transfer to ICU,prophylactic antibiotics, intubation of trachea (as required),administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure,volume replacement and pressor support (norepinephrine, vasopressin) as needed, NAC, correction of metabolic parameters and nutrition.

Treatment:

Drug: Prophylactic Antibiotics

Other: Transfer to Intensive Care Unit

Dietary Supplement: Correction of nutrition

Other: Correction of metabolic parameters

Drug: N-acetyl-L-cysteine

Other: Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure

Other: Intubation of trachea

Other: Management of cerebral edema/intracranial hypertension:

Other: Pressor Support

Other: Volume Replacement