Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472381
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2007-05-10
Brief Title:
Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2012-09
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:
INSULINFARCT
Brief Summary:
Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome But the modalities of glucose lowering are still debated This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke
Detailed Description:
It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome Yet the efficiency of aggressive insulin serum glucose control is not established Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration whereas some groups use intravenous administration of insulin The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin The study will include carotid territory stroke at the acute stage 6 hours of onset confirmed by MRI and randomized in intravenous versus subcutaneous insulin The percentage of patients in the target range mean capillary glycaemia within 24 hours 7 mmoll is the primary outcome The secondary outcomes include comparison of Modified Rankin Scale at 3 months rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI
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