Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (SHINE)
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|ClinicalTrials.gov Identifier: NCT01369069|
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : December 16, 2019
Last Update Posted : December 23, 2019
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|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||November 19, 2018|
|Actual Study Completion Date :||November 19, 2018|
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.
Other Name: Continuous intravenous insulin
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.
Other Name: Sliding scale insulin
- Number of Participants With a Favorable Modified Rankin Scale (Yes/No) [ Time Frame: 90 days (-14/+30 days) ]Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.
- Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL) [ 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.
- Number of Participants With a Favorable NIHSS [ Time Frame: Follow up (Max 164 days) ]The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.
- Number of Participants With a Favorable Barthel Index [ Time Frame: Follow up (Max 164 days) ]Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.
- Stroke Specific Quality of Life (SSQOL) [ Time Frame: Follow up (Max 164 days) ]Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life
- Death [ Time Frame: 90 days (+30 days) ]Death from any cause
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
- 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.
- 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)
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
|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|
Documents provided by Karen C. Johnston, University of Virginia:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Karen C. Johnston, Principal Investigator, University of Virginia|
|Other Study ID Numbers:||
U01NS069498 ( U.S. NIH Grant/Contract )
|First Posted:||June 8, 2011 Key Record Dates|
|Results First Posted:||December 16, 2019|
|Last Update Posted:||December 23, 2019|
|Last Verified:||December 2019|
Central Nervous System Diseases
Nervous System Diseases
Glucose Metabolism Disorders
Insulin, Globin Zinc
Physiological Effects of Drugs