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

NCT02460510 | Completed

• 1 other identifier: ILBS-ALF-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Correlation of arterial NH3 to raised ICT (Intra cranial Tension).

  2 years

• Survival.

  28 days

• Length of ICU/hospital stay.

  2 years

Study Arms (2)

Mannitol

EXPERIMENTAL

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

Drug: Mannitol

3% hypertonic saline

ACTIVE COMPARATOR

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.

Drug: 3% hypertonic saline

Interventions

Mannitol DRUG

Mannitol

3% hypertonic saline DRUG

3% hypertonic saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Mannitol; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 2, 2015
• Study Start: June 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

IN (1)