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

Acute Liver Failure Clinical Trial

Official title:

High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718079
• Other study ID #: ILBS-ALF-03
• Status: Completed
• Phase: N/A
• Start date: December 30, 2016
• Est. completion date: October 18, 2018

Study information

• Verified date: November 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 18, 2018
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Liver Failure
• Hepatic Insufficiency
• Liver Failure
• Liver Failure, Acute

Intervention

Biological:
• Plasma Exchange

Other:
• Management of cerebral edema/intracranial hypertension:

• Transfer to Intensive Care Unit

Drug:
• Prophylactic Antibiotics

Other:
• Intubation of trachea

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

• Volume Replacement

• Pressor Support

Drug:
• N-acetyl-L-cysteine

Other:
• Correction of metabolic parameters

Dietary Supplement:
• Correction of nutrition

Locations

Country	Name	City	State
India	Institute of liver and 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	Survival in both groups.		21 days
Secondary	Duration of Intensive Care Unit stay in both groups.		21 days
Secondary	Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.		48 hours
Secondary	Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.		day 5
Secondary	Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.		day 7
Secondary	Improvement in SOFA (Sequential Organ Failure Assessment) score.		48 hours
Secondary	Improvement in SOFA (Sequential Organ Failure Assessment) score.		day 5
Secondary	Improvement in SOFA (Sequential Organ Failure Assessment) score.		day 7
Secondary	Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.		48 hours
Secondary	Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.		Day 5
Secondary	Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.		Day 7
Secondary	Effect on systemic haemodynamics in both groups.	Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).	24 hours
Secondary	Effect on systemic haemodynamics in both groups.	Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome).	48 hours
Secondary	Pro inflammatory cytokines profile in both groups.		1 hour
Secondary	Serum Endotoxin levels in both groups.		1 hour