Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02460510
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-05-25
Brief Title:
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF A Randomized Open -Label Study
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mmolL 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None