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

Not Applicable

Completed

• Conditions: Acute Liver Failure
• Interventions: Drug: 3% hypertonic saline; Drug: Mannitol

• Registration Number: NCT02460510
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% hypertonic saline	3% hypertonic saline	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.
Mannitol	Mannitol	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

Primary Outcome Measures

Name	Time	Method
To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)	12 hours	ICP (Intra Cranial Pressure) as assessed by ONSD (Optic Nerve Sheet Diameter) \< 5mm PS\<1.2 Pupils - RTL(reaction to light) {if initially NTR(no reaction to light)} BP\<150/90(if initially high) Pulse \>60( if \< 60)

Secondary Outcome Measures

Name	Time	Method
Survival.	28 days
Correlation of arterial NH3 to raised ICT (Intra cranial Tension).	2 years
Length of ICU/hospital stay.	2 years

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India