Clinical Trial of Euglycemia Maintenance With Supraphysiologic Insulin vs Conventional Intensive Insulin Therapy to Improve Outcomes (Neurologic, Neuropsychiatric, and Biomarkers) After Surgical Treatment of Unruptured Cerebral Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Neurologic Outcome--"poor" vs. "good." A "poor" outcome is assigned if the patient who arrived independently from home is discharged to a nursing home or rehabilitation hospital or dies.
研究概览
简要总结
We hypothesize that in patients undergoing surgical treatment of unruptured intracranial aneurysms, the increase in blood sugar as a result of surgical stress is detrimental to outcome, as measured by blood levels of proteins associated with systemic inflammation and 7 day, 90 day, and 1 year postoperative neurologic and neuropsychiatric outcomes. Because insulin itself is an anti-inflammatory agent, we anticipate that normalizing blood sugar levels with insulin doses higher than normally produced by the body (i.e., "supraphysiologic" insulin doses) will have a greater benefit on these outcomes than equally normalizing blood sugar levels using normal insulin doses. Based on the results of this study, we will be able to determine if a more laborious strategy to normalize blood sugar levels (i.e., "supraphysiologic" insulin therapy) offers any additional benefits to normal insulin dosing strategies. In addition, we will obtain a robust assessment of postoperative neuropsychiatric and neurologic outcomes of surgically repaired unruptured intracranial aneurysms that will serve as the basis for future studies to decrease morbidity of these patients
详细描述
PREOPERATIVE NEUROPSYCHIATRIC & NEUROLOGIC TESTING Up to thirty days before the scheduled elective surgical repair of his or her intracranial aneurysm, each patient will undergo neuropsychological examination by a neuropsychologist or psychometrician and assessment of neurologic status by a research nurse or the neurosurgical attending from the Department of Neurological Surgery.
The battery of neuropsychological tests will include the following:
- Benton Visual Retention Test
- Controlled Oral Word Association
- Rey-Osterrieth Complex Figure Copy
- Grooved Pegboard
- Trial Making Test
- Hopkins Verbal Learning Test
The assessment of neurologic status and the time to administer each assessment is as follows:
- Glasgow Outcome Scale (2 minutes)
- Modified Rankin Disability Scale (5 minutes)
- NIH Stroke Scale (2 minutes)
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
- Triple (Participant, Investigator, 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
- •Unruptured intracranial aneurysm
排除标准
- •Pregnancy
- •Age less than 18 years
- •Inability to undergo preoperative neuropsychiatric and neurologic functional testing
研究组 & 干预措施
Normal insulin
Maintenance of intraoperative euglycemia (blood glucose 80--110 mg/dL) using normal intensive insulin infusion rates (0-10 U/hr).
干预措施: Insulin (Drug)
Supraphysiologic insulin
Maintenance of intraoperative euglycemia (blood glucose 80--110 mg/dL) using supraphysiologic insulin infusion doses (0.3 U/kg/hr) and exogenous dextrose to provide stable blood glucose levels .
干预措施: Insulin (Drug)
结局指标
主要结局
Neurologic Outcome--"poor" vs. "good." A "poor" outcome is assigned if the patient who arrived independently from home is discharged to a nursing home or rehabilitation hospital or dies.
时间窗: Discharge from hospital after surgery
次要结局
- Neuropsychiatric outcomes(Postoperative day 7, 90+/- 14 days, and 365+/-30 days)
- Neurologic Status (Glasgow Outcome Scale <=4; Modified Rankin Disability Scale >=2, NIH Stroke Scale <=10)(Postoperative day 7, 90+/- 14 days, and 365+/-30 days)
- Amount of time blood glucose concentration is outside the target glucose concentration range (80-120 mg/dL)(Perioperative Period (Induction of anesthesia + 24 hrs))
- Biomarkers of the Perioperative Inflammatory Response(Perioperative Period (Induction of anesthesia + 48 hrs))
研究者
Dhanesh Gupta
Associate Professor of Anesthesiology & Neurological Surgery
Northwestern University