Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
NCT ID: NCT01369069
Last Updated: 2019-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1151 participants
INTERVENTIONAL
2012-04-30
2018-11-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Neurological Emergencies Treatment Trials Network (NETT)
NETWORK
Medical University of South Carolina
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Virginia
OTHER
Responsible Party
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Karen C. Johnston
Principal Investigator
Principal Investigators
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Karen C Johnston, MD, MSc
Role: STUDY_CHAIR
University of Virginia
Christiana Hall, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Askiel Bruno, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Valerie Durkalski, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
William Barsan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Kevin Barrett, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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University of Arizona Medical Center - South Campus
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Ronald Regan Medical Center
Los Angeles, California, United States
San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center - Davies Campus
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Emory University Hospital - Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital-Troy
Troy, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
JFK Medical Center
Edison, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Kings County Hospital
Brooklyn, New York, United States
SUNY Downstate University Hospital of Brooklyn
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Maimonides Medical Center
New York, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
Summa Akron City Hospital
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Wexner Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC - Mercy
Pittsburgh, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
St. Thomas Neuroscience Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dell Seton Medical Center at UT
Austin, Texas, United States
Seton Medical Center
Austin, Texas, United States
UT Southwestern-Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern-Zale Lipshy University Hospital
Dallas, Texas, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Memorial Herman Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
Southerland AM, Mayer SA, Chiota-McCollum NA, Bolte AC, Pauls Q, Pettigrew LC, Bleck TP, Conaway M, Johnston KC. Glucose Control and Risk of Symptomatic Intracerebral Hemorrhage Following Thrombolysis for Acute Ischemic Stroke: A SHINE Trial Analysis. Neurology. 2024 May 14;102(9):e209323. doi: 10.1212/WNL.0000000000209323. Epub 2024 Apr 16.
Arteaga DF, Ulep R, Kumar KK, Southerland AM, Conaway MR, Faber J, Wintermark M, Joyner D, Sharashidze V, Hirsch K, Giurgiutiu DV, Hannawi Y, Aziz Y, Shutter L, Visweswaran A, Williams A, Williams K, Gunter S, Haughey HM, Bruno A, Johnston KC, Patel VN; SHINE Trial Investigators. Collateral status, hyperglycemia, and functional outcome after acute ischemic stroke. BMC Neurol. 2022 Nov 4;22(1):408. doi: 10.1186/s12883-022-02943-4.
Connor JT, Broglio KR, Durkalski V, Meurer WJ, Johnston KC. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials. 2015 Mar 4;16:72. doi: 10.1186/s13063-015-0574-8.
Garofolo KM, Yeatts SD, Ramakrishnan V, Jauch EC, Johnston KC, Durkalski VL. The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes. Trials. 2013 Apr 11;14:98. doi: 10.1186/1745-6215-14-98.
Bruno A, Durkalski VL, Hall CE, Juneja R, Barsan WG, Janis S, Meurer WJ, Fansler A, Johnston KC; SHINE investigators. The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial protocol: a randomized, blinded, efficacy trial of standard vs. intensive hyperglycemia management in acute stroke. Int J Stroke. 2014 Feb;9(2):246-51. doi: 10.1111/ijs.12045. Epub 2013 Mar 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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General information of trial
Other Identifiers
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15959
Identifier Type: -
Identifier Source: org_study_id