SHINE

Overview

Status: Recruiting
Keywords: Acute Ischemic Stroke , Glucose Management , GlucoStabalizer
IRB Number: 00053442
Specialty: Neurology, Neurology
Sub Specialties: Neuro Critical Care, Stroke

Brief Summary

There is an increasing need for improved treatments for stroke patients as stroke is the most common cause of serious long term adult disability and the third most common cause of death in the United States. Hyperglycemia is seen in approximately 40% of acute ischemic stroke patients and has been associated with worse clinical outcomes.
 
Intravenous (IV) insulin therapy with tight glucose control has been found to improve clinical outcomes in some non-stroke acute illness trials. Current stroke guidelines emphasize the need for definitive clinical trials to determine best practice for managing hyperglycemia in acute stroke patients. A clear determination of the risk and benefit of glucose control with IV insulin would have a dramatic impact on acute ischemic stroke patient therapy.
 
Objective #1: To determine the efficacy of tight glucose control to a target range of 80-130 mg/dL with IV insulin infusion in hyperglycemic acute ischemic stroke patients within 12 hours of symptom onset as measured by mRS at 90 days after stroke.
 
Objective #2: To determine the safety of tight glucose control with IV insulin infusion in hyperglycemic acute ischemic stroke patients treated for up to 72 hrs.
 

Principal Investigator: Jana Wold
Department: Neurology
Co Investigator: Safdar Ansari
Co Investigator: Dana DeWitt
Co Investigator: Jennifer Majersik

Contact Information

Name:Suyi Niu
Phone: 801-587-8046
Email: suyi.niu@hsc.utah.edu

Inclusion Criteria

(1) Age 18 years or older
 
(2) Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
 
(3) Protocol treatment is recommended, but not required, to begin within 3 hours after hospital arrival and within 12 hours after stroke symptom onset. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
 
(4) Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission glucose ≥150 mg/dL in those w/o known diabetes mellitus
 
(5) Baseline NIHSS score of 3-22
 
(6) Pre-stroke Modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7, pre-stroke Modified Rankin Sclae = 0 or 1 for patients with an NIHSS scoreof 8-22.
 
(7) Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines

Exclusion Criteria

(1) Known history of type1 diabetes mellitus
 
(2) Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
 
(3) Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
 
(4) Known to be pregnant or breast-feeding at the time of study entry
 
(5) Other serious conditions that make the patient unlikely to survive 90 days
 
(6) Inability to follow the protocol or return for the 90 day follow up
 
(7) Renal dialysis (including hemo or peritoneal dialysis)