Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

• Status: Completed
• Trial end date: 2018-11-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); Neurological Emergencies Treatment Trials Network (NETT)
• Treatments: Benzocaine; Insulin; Insulin, Globin Zinc

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)