ClinicalTrials.gov
ClinicalTrials.gov Menu

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (SHINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01369069
Recruitment Status : Active, not recruiting
First Posted : June 8, 2011
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Karen C. Johnston, University of Virginia

Brief 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 randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher 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 5-7 years.


Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Diabetes Hyperglycemia Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
Actual Study Start Date : April 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: IV insulin drip with target glucose 80 mg/dL - 130 mg/dL
The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.
Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
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.

Active Comparator: Sub Q insulin to keep glucose less than 180 mg/dL
This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL
Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL
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.




Primary Outcome Measures :
  1. modified Rankin Scale Score [ Time Frame: 3 months ]
    a 3 month (post stroke) modified Rankin scale score is the primary efficacy outcome measure.

  2. Hypoglycemia [ Time Frame: 72 hours ]
    Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369069


  Hide Study Locations
Locations
United States, Arizona
University of Arizona Medical Center - South Campus
Tucson, Arizona, United States, 85713
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Ronald Regan Medical Center
Los Angeles, California, United States, 90095
San Francisco General Hospital
San Francisco, California, United States, 94110
California Pacific Medical Center - Davies Campus
San Francisco, California, United States, 94114
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States, 94114
UCSF Medical Center
San Francisco, California, United States, 94117
Stanford University Medical Center
Stanford, California, United States, 94305
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital - Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States, 30322
Augusta University Medical Center
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Troy
Troy, Michigan, United States, 48085
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
JFK Medical Center
Edison, New Jersey, United States, 08818
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
Kings County Hospital
Brooklyn, New York, United States, 11203
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, United States, 11203
Buffalo General Medical Center
Buffalo, New York, United States, 14210
The Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medical Center
New York, New York, United States, 10065
Maimonides Medical Center
New York, New York, United States, 11219
United States, Ohio
Summa Akron City Hospital
Akron, Ohio, United States, 44307
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Wexner Medical Center
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC - Mercy
Pittsburgh, Pennsylvania, United States, 15219
WellSpan York Hospital
York, Pennsylvania, United States, 17403
United States, Tennessee
St. Thomas Neuroscience Research Institute
Nashville, Tennessee, United States, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Seton Medical Center at UT
Austin, Texas, United States, 78701
Seton Medical Center
Austin, Texas, United States, 78705
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, United States, 75390
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Valley Baptist Medical Center
Harlingen, Texas, United States, 78552
Baylor College of Medicine
Houston, Texas, United States, 77030
Memorial Herman Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Virginia
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Study Chair: Karen C Johnston, MD, MSc University of Virginia
Principal Investigator: Christiana Hall, MD, MS UT Southwestern
Principal Investigator: Askiel Bruno, MD, MS Augusta University
Principal Investigator: Valerie Durkalski, PhD Medical University of South Carolina
Principal Investigator: William Barsan, MD University of Michigan
Principal Investigator: Kevin Barrett, MD Mayo Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen C. Johnston, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01369069     History of Changes
Other Study ID Numbers: 15959
U01NS069498 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Karen C. Johnston, University of Virginia:
stroke
diabetes
hyperglycemia

Additional relevant MeSH terms:
Stroke
Hyperglycemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Benzocaine
Hypoglycemic Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents