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

Acute Stroke Clinical Trial

— INSULINFARCT  

Official title:

Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472381
• Other study ID #: P060202
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 10, 2007
• Last updated: June 4, 2014
• Start date: May 2007
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Cerebral Ischemia
• Acute Stroke
• Cerebral Infarction
• Stroke

Intervention

Drug:
• Insulin
Insulin

Locations

Country	Name	City	State
France	AP-HP Urgences cerebro vasculaires La Pitié Salpétrière	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Samson Y, Bruandet M, Lejeune M, Deltour S, Grimaldi A. [Insulin in the treatment of ischemic stroke]. Presse Med. 2006 Apr;35(4 Pt 2):696-8. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.		24 hours	Yes
Secondary	Modified Rankin Scale at three months		three months	Yes
Secondary	Magnetic resonance imaging (MRI) infarct growth at one day		one day	Yes
Secondary	Percentage of patients with hypoglycaemic event (< 3 mmol/l)		during the study	Yes

External Links

•   DOI:10.1161/STROKEAHA.112.657122