Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,151
- 试验地点
- 70
- 主要终点
- Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: IV insulin to maintain target glucose concentration of 80-130 mg/dL (Drug)
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
干预措施: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL (Drug)
结局指标
主要结局
Number of Participants With a Favorable Modified Rankin Scale (Yes/No)
时间窗: 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)
时间窗: 72 hours
Severe hypoglycemia (blood glucose \< 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.
次要结局
- Stroke Specific Quality of Life (SSQOL)(Follow up (Max 164 days))
- Number of Participants With a Favorable NIHSS(Follow up (Max 164 days))
- Number of Participants With a Favorable Barthel Index(Follow up (Max 164 days))
研究者
Karen C. Johnston
Principal Investigator
University of Virginia