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
|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
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|