Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF

Acute Liver Failure Clinical Trial

Official title: Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF: A Randomized Open -Label Study

Status Completed

Clinical Trial Summary

Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Liver Failure
• Intracranial Hypertension
• Liver Failure
• Liver Failure, Acute

• NCT number: NCT02460510
• Study type: Interventional
• Source: Institute of Liver and Biliary Sciences, India
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Completion date: November 2015