Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Acute Stroke; Acute Cerebral Ischemia
• Interventions: Drug: Insulin

• Registration Number: NCT00472381
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-09
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age over 18 years
• Carotid territory stroke
• MRI performed in the first five hours of stroke onset
• Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
• Time between MRI and treatment under one hour

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Exclusion Criteria

• Pre-existing Modified Rankin Scale of three or higher
• Advanced or terminal illness with risk of death in the next 6 months, addiction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Insulin	Insulin

Primary Outcome Measures

Name	Time	Method
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.	24 hours

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale at three months	three months
Magnetic resonance imaging (MRI) infarct growth at one day	one day
Percentage of patients with hypoglycaemic event (< 3 mmol/l)	during the study

Trial Locations

Locations (1)

AP-HP Urgences cerebro vasculaires La Pitié Salpétrière; 🇫🇷 Poissy, France