Trial record 1 of 1 for:
NCT01369069
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (SHINE)
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| ClinicalTrials.gov Identifier: NCT01369069 |
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Recruitment Status :
Completed
First Posted : June 8, 2011
Results First Posted : December 16, 2019
Last Update Posted : December 23, 2019
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Sponsor:
University of Virginia
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
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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.
| 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 |
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 include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates 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.
| 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 |
| Actual Primary Completion Date : | November 19, 2018 |
| Actual Study Completion Date : | November 19, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hyperglycemia
| Arm | Intervention/treatment |
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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.
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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 |
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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
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
Other Outcome Measures:
- Death [ Time Frame: 90 days (+30 days) ]Death from any cause
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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).
- 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.
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)
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
Locations
Show 70 study locations
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 |
Study Documents (Full-Text)
Documents provided by Karen C. Johnston, University of Virginia:
Documents provided by Karen C. Johnston, University of Virginia:
Study Protocol [PDF] October 23, 2012
Statistical Analysis Plan [PDF] January 8, 2015
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
| ClinicalTrials.gov Identifier: | NCT01369069 |
| Other Study ID Numbers: |
15959 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 |
Keywords provided by Karen C. Johnston, University of Virginia:
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stroke diabetes hyperglycemia |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Hyperglycemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Glucose Metabolism Disorders Metabolic Diseases Insulin Insulin, Globin Zinc Hypoglycemic Agents Physiological Effects of Drugs |