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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris CNRS UPR 640 LENA Clinical Research Unit |
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00472381 |
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.
Condition | Intervention | Phase |
Acute Stroke Acute Cerebral Ischemia |
Drug: Insulin |
Phase II Phase III |
Drug Information available for: | Insulin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke |
Estimated Enrollment: | 180 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | September 2009 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yves Samson, MD,PhD | +33(0) 1 42 16 18 54 | yves.samson@psl.aphp.fr |
France | |||||
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière | Recruiting | ||||
POISSY, France, 75013 | |||||
Contact: Yves Samson, MD,PhD +33(0) 1 42 16 18 54 yves.samson@psl.aphp.fr |
Assistance Publique - Hôpitaux de Paris |
CNRS UPR 640 LENA |
Clinical Research Unit |
Principal Investigator: | Yves Samson, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P060202, SCR06011 |
First Received: | May 10, 2007 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00472381 |
Health Authority: | France: Ministry of Health |
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