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Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
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.
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 mmol/l) 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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Poissy, France
Start Date
May 1, 2007
Primary Completion Date
June 1, 2012
Completion Date
June 1, 2012
Last Updated
June 5, 2014
180
ACTUAL participants
Insulin
DRUG
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
NCT07236216
NCT05955326
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07204067