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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460510
• Other study ID #: ILBS-ALF-01
• Status: Completed
• Phase: N/A
• First received: May 25, 2015
• Last updated: February 15, 2016
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Intervention

Drug:
• Mannitol

• 3% hypertonic saline

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	To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)	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)	12 hours	No
Secondary	Correlation of arterial NH3 to raised ICT (Intra cranial Tension).		2 years	No
Secondary	Survival.		28 days	Yes
Secondary	Length of ICU/hospital stay.		2 years	No