Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
Primary Purpose
Acute Liver Failure
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Mannitol
3% hypertonic saline
Sponsored by
About this trial
This is an interventional treatment trial for Acute Liver Failure
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mannitol
3% hypertonic saline
Arm 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 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Correlation of arterial NH3 to raised ICT (Intra cranial Tension).
Survival.
Length of ICU/hospital stay.
Full Information
NCT ID
NCT02460510
First Posted
May 25, 2015
Last Updated
February 15, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02460510
Brief Title
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
Official Title
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF: A Randomized Open -Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mannitol
Arm Type
Experimental
Arm 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
Arm Title
3% hypertonic saline
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Type
Drug
Intervention Name(s)
3% hypertonic saline
Primary Outcome Measure Information:
Title
To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)
Description
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)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Correlation of arterial NH3 to raised ICT (Intra cranial Tension).
Time Frame
2 years
Title
Survival.
Time Frame
28 days
Title
Length of ICU/hospital stay.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
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