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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Insulin
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Poissy, France
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.
Time frame: 24 hours
Modified Rankin Scale at three months
Time frame: three months
Magnetic resonance imaging (MRI) infarct growth at one day
Time frame: one day
Percentage of patients with hypoglycaemic event (< 3 mmol/l)
Time frame: during the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.