Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
This study is currently recruiting participants.
Verified April 2013 by University of Virginia
Sponsor:
University of Virginia
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
Medical Automation Systems, an Alere Company
Information provided by (Responsible Party):
Karen C. Johnston, University of Virginia
ClinicalTrials.gov Identifier:
NCT01369069
First received: June 6, 2011
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial |
Resource links provided by NLM:
Further study details as provided by University of Virginia:
Primary Outcome Measures:
- modified Rankin Scale Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]a 3 month (post stroke) modified Rankin scale score is the primary efficacy outcome measure.
- Hypoglycemia [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period
| Estimated Enrollment: | 1400 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older
- 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).
- 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.
- 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
- Baseline NIHSS score of 3-22
- 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.
- 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:
- Known history of type 1 diabetes mellitus
- Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
- 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.
- Pregnant or breast-feeding at the time of study entry
- Other serious conditions that make the patient unlikely to survive 90 days
- Inability to follow the protocol or return for the 90 day follow up
- Renal dialysis (including hemo or peritoneal dialysis)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369069
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Contacts
| Contact: Karen C Johnston, MD, MSc | 434-924-5323 | kj4v@virginia.edu |
| Contact: Amy C Fansler, MPH | 434-982-6027 | acf7h@virginia.edu |
Hide Study LocationsLocations
| United States, Arizona | |
| University of Arizona | Not yet recruiting |
| Tucson, Arizona, United States, 85724 | |
| Contact: Kendra Drake, MD | |
| Principal Investigator: Kendra Drake | |
| United States, California | |
| Long Beach Memorial Medical Center | Not yet recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Sidney Starkman, MD starkman@ucla.edu | |
| Principal Investigator: Sidney Starkman, MD | |
| Ronald Regan Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Sidney Starkman, MD starkman@ucla.edu | |
| Contact: Ileana Grunberg igrunberg@mednet.ucla.edu | |
| Principal Investigator: Sidney Starkman, MD | |
| Huntington Memorial Hospital | Not yet recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: Sidney Starkman, MD starkman@ucla.edu | |
| Principal Investigator: Sidney Starkman, MD | |
| California Pacific Medical Center - Davies Campus | Recruiting |
| San Francisco, California, United States, 94114 | |
| Contact: Nobl Barazangi, MD BarazaN@sutterhealth.org | |
| Contact: Katie Ponting pontink@cpmcri.org | |
| Principal Investigator: Nobl Barazangi | |
| UCSF Medical Center | Not yet recruiting |
| San Francisco, California, United States, 94117 | |
| Contact: Claude Hemphill, MD | |
| Principal Investigator: Claude Hemphill, MD | |
| California Pacific Medical Center-Pacific Campus | Recruiting |
| San Francisco, California, United States, 94114 | |
| Contact: Nobl Barazangi BarazaN@sutterhealth.org | |
| Contact: Katie Ponting pontink@cpmcri.org | |
| Principal Investigator: Nobl Barazangi, MD | |
| San Francisco General Hospital | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Claude Hemphill, MD chemphill@sfgh.ucsf.edu | |
| Contact: Michele Meeker MeekerM@neurosurg.ucsf.edu | |
| Principal Investigator: Claude Hemphill, MD | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Chitra Venkat, MD chitrav@stanford.edu | |
| Contact: Ryan Snider rsnider@stanford.edu | |
| Principal Investigator: James Quinn, MD | |
| United States, Florida | |
| Mayo Clinic Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Kevin M Barrett, MD Barrett.kevin@mayo.edu | |
| Contact: Alexa Richie Richie.Alexa@mayo.edu | |
| Principal Investigator: Kevin Barrett, MD | |
| United States, Georgia | |
| Grady Memorial Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Vishal Patel, MD vishal.patel@emory.edu | |
| Contact: Alex Hall alex.hall@emory.edu | |
| Principal Investigator: Vishal Patel, MD | |
| Georgia Health Sciences University | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Askiel Bruno, MD, MS abruno@georgiahealth.edu | |
| Contact: Brian Close bclose@georgiahealth.edu | |
| Principal Investigator: Askiel Bruno, MD | |
| United States, Illinois | |
| Loyola University Chicago | Not yet recruiting |
| Chicago, Illinois, United States, 60626 | |
| Contact: Tom Aufderheide, MD | |
| Principal Investigator: Tom Aufderheide, MD | |
| OSF Saint Francis Medical Center | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| Contact: Deepak Nair, MD Deepak.Nair@osfhealthcare.org | |
| Contact: Judith Beck judith.m.beck@osfhealthcare.org | |
| Principal Investigator: Deepak Nair, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40506 | |
| Contact: Roger L Humphries, MD roger.humphries@uky.edu | |
| Contact: Linda Dechtenberg ldech3@email.uky.edu | |
| Principal Investigator: Roger L Humphries, MD | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Marcella Wozniak, MD, PhD MWozniak@som.umaryland.edu | |
| Contact: Virginia Ganley vganley@som.umaryland.edu | |
| Principal Investigator: Marcella Wozniak, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Chris Anderson, MD cdanderson@partners.org | |
| Contact: Eric Riklin eriklin@partners.org | |
| Principal Investigator: Chris Anderson, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Jeffrey Fletcher, MD jeffletc@med.umich.edu | |
| Contact: Allie Kade akade@med.umich.edu | |
| Principal Investigator: Jeffrey Fletcher, MD | |
| Detroit Receiving Hospital | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Gregory Norris, MD gnorris@med.wayne.edu | |
| Contact: Valerie Mika vmika@med.wayne.edu | |
| Principal Investigator: Gregory Norris, MD | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Chris Lewandowski, MD clewand1@hfhs.org | |
| Contact: Anne Marie Lundell ALUNDEL1@hfhs.org | |
| Principal Investigator: Chris Lewandowski, MD | |
| Sinai-Grace Hospital | Not yet recruiting |
| Detroit, Michigan, United States, 48235 | |
| Contact: Robert Welch, MD rwelch@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| Harper University | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Robert Welch, MD rwelch@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| William Beaumont Hospital-Royal Oak | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Robert Swor, MD raswor@beaumont.edu | |
| Contact: Megan Hausler Megan.Hausler@beaumont.edu | |
| Principal Investigator: Robert Swor, DO | |
| William Beaumont Hospital-Troy | Recruiting |
| Troy, Michigan, United States, 48085 | |
| Contact: Aveh Bastani, MD ABastani@beaumont.edu | |
| Contact: Kristen Palomba Kristen.Palomba@beaumont.edu | |
| Principal Investigator: Aveh Bastani, MD | |
| United States, Minnesota | |
| University of Minnesota Medical Center, Fairview | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Mustapha Ezzeddine, MD ezzeddin@umn.edu | |
| Contact: Julie Scherber JScherber@yahoo.com | |
| Principal Investigator: Mustapha Ezzeddine, MD | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Mustapha Ezzeddine, MD ezzeddin@umn.edu | |
| Contact: Julie Scherber JScherber@yahoo.com | |
| Principal Investigator: Mustapha Ezzeddine, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Joseph Feldman, MD JFeldman@HackensackUMC.org | |
| Contact: Gordon Huie GHuie@HackensackUMC.org | |
| Principal Investigator: Joseph Feldman, MD | |
| United States, New York | |
| Lincoln Medical and Mental Health Center | Not yet recruiting |
| Bronx, New York, United States, 10451 | |
| Contact: Steven Levine, MD Steven.Levine@downstate.edu | |
| Principal Investigator: Steven Levine, MD | |
| SUNY Downstate University Hospital of Brooklyn | Not yet recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Steven Levine, MD Steven.Levine@downstate.edu | |
| Principal Investigator: Steven Levine, MD | |
| Kings County Hospital | Not yet recruiting |
| Brooklyn, New York, United States, 11203 | |
| Contact: Jennifer Martindale, MD rtindale.jen@gmail.com | |
| Principal Investigator: Jennifer Martindale, MD | |
| Long Island College Hospital | Not yet recruiting |
| Brooklyn, New York, United States, 11201 | |
| Contact: Steven Levine, MD Steven.Levine@downstate.edu | |
| Principal Investigator: Steven Levine, MD | |
| Kaleida Stroke Center, SUNY Buffalo | Not yet recruiting |
| Buffalo, New York, United States, 14210 | |
| Contact: Marilou Ching, MD marilouching@aol.com | |
| Contact: Anne Marie Crumlish ac35@buffalo.edu | |
| Principal Investigator: Marilou Ching, MD | |
| Maimonides Medical Center | Not yet recruiting |
| New York, New York, United States, 11219 | |
| Contact: Christian Fromm, MD CFromm@maimonidesmed.org | |
| Principal Investigator: Christian Fromm, MD | |
| Weill Cornell Medical Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Halinder Mangat, MD hsm9001@med.cornell.edu | |
| Contact: Entila Xhori enx9001@nyp.org | |
| Principal Investigator: Halinder Mangat, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Stephan Mayer, MD sam14@columbia.edu | |
| Contact: Cristina Falo maf9135@nyp.org | |
| Principal Investigator: Stephan Mayer, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45221 | |
| Contact: Opeolu Adeoye, MD adeoyeo@ucmail.uc.edu | |
| Contact: Irene Ewing ewingi@ucmail.uc.edu | |
| Principal Investigator: Opeolu Adeoye, MD | |
| Wexner Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Michel Torbey, MD Michel.Torbey@osumc.edu | |
| Contact: April Spangler April.Spangler@osumc.edu | |
| Principal Investigator: Michel Torbey, MD | |
| United States, Oregon | |
| Oregon Health Sciences University | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Wayne Clark, MD | |
| Principal Investigator: Wayne Clark, MD | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | Not yet recruiting |
| Abington, Pennsylvania, United States, 19001 | |
| Contact: David Weisman, MD dcweisman@gmail.com | |
| Principal Investigator: David Weisman, MD | |
| Penn State Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Kerstin Bettermann, MD kbettermann@hmc.psu.edu | |
| Contact: Deborah Hoffman dhoffman1@hmc.psu.edu | |
| Principal Investigator: Kerstin Bettermann, MD | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Nina Gentile, MD ngentile@temple.edu | |
| Contact: Brent Freeman freemanb@temple.edu | |
| Principal Investigator: Nina Gentile, MD | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Brett Cucchiara, MD brett.cucchiara@uphs.upenn.edu | |
| Contact: Melissa Kruszewski ssa.kruszewski@uphs.upenn.edu | |
| Principal Investigator: Brett Cucchiara, MD | |
| Jefferson Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Jacqueline Urtecho, MD Jacqueline.Urtecho@jefferson.edu | |
| Contact: Amanda Salvatore amanda.salvatore@jefferson.edu | |
| Principal Investigator: Jacqueline Urtecho, MD | |
| UPMC Presbyterian | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Lori Shutter, MD shutterla@upmc.edu | |
| Contact: Sara DiFiore vandruffsm@upmc.edu | |
| Principal Investigator: Clifton Callaway, MD | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Crystal Wong, MD cwong@wpahs.org | |
| Contact: Gail Love glove@wpahs.org | |
| Principal Investigator: Crystal Wong, MD | |
| UPMC - Mercy | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Contact: Clifton Callaway, MD | |
| Principal Investigator: Lori Shutter, MD | |
| United States, Texas | |
| UT Southwestern | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Christiana Hall, MD, MS Christiana.Hall@utsouthwestern.edu | |
| Contact: Katrina van de Bruinhorst Katrina.vandebruinhorst@utsouthwestern.edu | |
| Principal Investigator: Christiana Hall, MD, MS | |
| Memorial Herman Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Elizabeth Jones, MD elizabeth.b.jones@uth.tmc.edu | |
| Contact: Misty Ottman misty.ottman@uth.tmc.edu | |
| Principal Investigator: Elizabeth Jones, MD | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jose Suarez, MD jisuarez@bcm.edu | |
| Contact: Eusebia Calvillo eusebiac@bcm.edu | |
| Principal Investigator: Jose I Suarez, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Jana Wold, MD jana.wold@hsc.utah.edu | |
| Contact: Suyi Niu SUYI.NIU@hsc.utah.edu | |
| Principal Investigator: Jana Wold, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Karen C Johnston, MD, MSc kj4v@virginia.edu | |
| Contact: Amy C Fansler, MPH acf7h@virginia.edu | |
| Principal Investigator: Karen C Johnston, MD, MSc | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Warren Felton, MD wlfelton@vcu.edu | |
| Contact: Margot Lee mplee@vcu.edu | |
| Principal Investigator: Warren Felton | |
| United States, Washington | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: David Tirschwell, MD tirsch@uw.edu | |
| Contact: Glenn Schubert gbs61@u.washington.edu | |
| Principal Investigator: David Tirschwell, MD | |
| United States, West Virginia | |
| West Virginia University | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Laurie Gutmann, MD lagutmann@hsc.wvu.edu | |
| Contact: Pat Altemus paltemus@hsc.wvu.edu | |
| Principal Investigator: Laurie Gutmann, MD | |
| United States, Wisconsin | |
| Froedtert Memorial Hospital | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: John Lynch, MD jlynch@mcw.edu | |
| Contact: Melissa Boettcher mboettcher@mcw.edu | |
| Principal Investigator: John Lynch, MD | |
Sponsors and Collaborators
University of Virginia
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
Medical Automation Systems, an Alere Company
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 | Georgia Regents University |
| Principal Investigator: | Valerie Durkalski, PhD | Medical University of South Carolina |
| Principal Investigator: | William Barsan, MD | University of Michigan |
More Information
Additional Information:
No publications provided
| Responsible Party: | Karen C. Johnston, Principal Investigator, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01369069 History of Changes |
| Other Study ID Numbers: | 15959, U01NS069498 |
| Study First Received: | June 6, 2011 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
stroke diabetes hyperglycemia |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperglycemia Stroke Cerebral Infarction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013