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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL. The primary outcome will be functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.

Keywords

Acute Ischemic Stroke Diabetes Hyperglycemia stroke Insulin, Globin Zinc Insulin Benzocaine

Eligibility

You can join if…

Open to people ages 18 years and up

  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 must begin within 12 hours after stroke symptom onset and 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.

You CAN'T join if...

  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)

Locations

  • California Pacific Medical Center - Davies Campus in progress, not accepting new patients
    San Francisco, California, 94114, USA
  • California Pacific Medical Center-Pacific Campus in progress, not accepting new patients
    San Francisco, California, 94114, USA
  • Stanford University Medical Center accepting new patients
    Stanford, California, 94305, USA
  • Long Beach Memorial Medical Center accepting new patients
    Long Beach, California, 90806, USA
  • Ronald Regan Medical Center accepting new patients
    Los Angeles, California, 90095, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Virginia
Links
http://shinetrial.com
ID
NCT01369069
Phase
Phase 3
Lead Scientist
Jesse Hemphill
Study Type
Interventional
Last Updated
September 2016
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