The Effect of Insulin on Infarct Size and Neurologic Outcome After Acute Stroke

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 11
• Participant gender: Both

Summary

Between twenty and fifty percent of people who have acute stroke have hyperglycemia (high blood sugar) with it. Research has shown an association between hyperglycemia and poor recovery from stroke. However, it is not known if treating the hyperglycemia—bringing the blood sugar back to normal range—will improve the patient's recovery from stroke. This purpose of this study is to see if giving Insulin to normalize the blood sugar will decrease the size of the stroke in the brain and improve the patient's neurologic recovery.

We hypothesize that early insulin administration to normalize blood glucose levels may be beneficial in cerebral ischemia and stroke.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Treatments: Insulin; Insulin, Globin Zinc
• Last Updated: 2015-04-10

Criteria

Inclusion Criteria:

• Patients aged > 18 years presenting to the Emergency Department with symptoms of acute ischemic stroke will be included for study.

• Acute stroke patients with normal blood glucose levels and patients with fingerstick blood glucose level of greater than or equal to 130 mg/dl will be eligible for study.

• Acute Stroke will be defined as an acute disturbance of cerebral function of presumed vascular origin causing a neurological deficit of less than 24 hours duration.

• Patients must have an NIH Stroke Scale Score of 4 to 23. Patients awakening with symptoms of stroke will be considered to have had their stroke at the time when last awake without symptoms.

Exclusion Criteria:

• Patients presenting after 24 hours of symptom onset. When the actual time of onset is unknown, the time when last observed to be symptom-free will be used.

• Patients with NIH scale of less than 4 or greater than 23.

• Complete or substantial resolution of symptoms before randomization.

• Patients with a previously disabling stroke (modified Rankin score > 3)

• Patients with other systemic disease such as infection (eg pneumonia, etc)

• Patients with hemorrhage visualized on CT.

• Patients who are unwilling or unable to give informed consent, or for whom a legally authorized representative is not able to consent.

• Pregnant patients.