Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
Condition: Acute Ischemic Stroke; Diabetes; Hyperglycemia
MeSH terms: Stroke; Ischemic Stroke; Hyperglycemia
Intervention: IV insulin to maintain target glucose concentration of 80-130 mg/dL; Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
Intervention description: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.; Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; diabetes; hyperglycemia

Summary:

      The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized,
      controlled clinical trial of 1400 patients that will include approximately 60 enrolling
      sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke
      patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in
      improved 3 month outcome after stroke.
    

Eligibility criteria:

        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. Randomization must be within 12 hours after stroke symptom onset and treatment is
             recommended, but not required, to begin within 3 hours after hospital arrival. 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 blood
             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 Scale score = 0 or 1 for patients with an NIHSS score of
             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 type 1 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. 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)