Clinical trial NCT00472381: Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke
Official title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Stroke
Acute Cerebral Ischemia
Keywords: Acute Ischemic Stroke
Post-Stroke Hyperglycaemia
Insulin treatment
Insulin
DWI
MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.
timeFrame: 24 hours
Secondary outcomes:
measure: Modified Rankin Scale at three months
timeFrame: three months
measure: Magnetic resonance imaging (MRI) infarct growth at one day
timeFrame: one day
measure: Percentage of patients with hypoglycaemic event (< 3 mmol/l)
timeFrame: during the study
Other outcomes:
Locations:
city: Poissy
country: France
facility: AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yves Samson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0755-4982(06)74664-4. French.
citation: Rosso C, Pires C, Corvol JC, Baronnet F, Crozier S, Leger A, Deltour S, Valabregue R, Amor-Sahli M, Lehericy S, Dormont D, Samson Y. Hyperglycaemia, insulin therapy and critical penumbral regions for prognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One. 2015 Mar 20;10(3):e0120230. doi: 10.1371/journal.pone.0120230. eCollection 2015.
citation: Rosso C, Corvol JC, Pires C, Crozier S, Attal Y, Jacqueminet S, Deltour S, Multlu G, Leger A, Meresse I, Payan C, Dormont D, Samson Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012 Sep;43(9):2343-9. doi: 10.1161/STROKEAHA.112.657122. Epub 2012 Jun 14.