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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute Liver Failure

Treatments: Drug: Mannitol; Drug: 3% hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02460510

ILBS-ALF-01

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Acute Liver Failure with age >18 yrs
• Grade III or grade IV HE with raised ICP
• Patient's next-of-kin consenting for the study protocol.

Exclusion criteria

• Patients with ocular trauma.
• K/c/o DCM, congestive heart failure, cerebral aneurysm, intracranial pathology
• Serum Na>160 and s creat>1.5 mg% with oligurea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Mannitol

Experimental group

Description:

Treatment with mannitol intravenous (IV) bolus over 20 to 30 minutes. The dose is 0.25 g/kg IV as a 20% solution repeated every 4th hourly.(8) Mannitol infusion to be stopped if s osmolarity \>320mm

Treatment:

Drug: Mannitol

3% hypertonic saline

Active Comparator group

Description:

Treatment with 3% hypertonic saline as continuous infusion. Continuous 3% NaCl infusion to be started at a rate of 25ml /hr and titrated q4hrs per sliding scale to achieve a target serum sodium level of \<160 mmol/L.

Treatment:

Drug: 3% hypertonic saline