Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
2018年2月7日 更新者：The Cleveland Clinic
The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
Patients undergoing cardiac surgery will be randomized into one of two groups.
Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively.
Group B will be administered insulin at the standard of care levels established by the participating institution.
Patients will be followed at 10 days, 15 days and one year post-operatively.
研究概览
地位
完全的
条件
详细说明
Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.
研究类型
介入性
注册 (实际的)
1439
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
Exclusion Criteria:
- Off-pump surgical procedures
- Anticipated deep hypothermic circulatory arrest
- In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
- Any contraindications to the proposed interventions
- Active infection, including patients with endocarditis or infected pacemaker leads.
- Any infection requiring long- term antibiotics ( > 14 days)
- kidney disease requiring renal replacement therapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Hyperinsulinemic-normoglycemic clamp
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
|
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
其他名称：
|
|
其他：Insulin at the standard of care levels
Group B will be administered insulin at the standard of care levels established by the participating institution.
|
Subjects will be administered insulin at the standard of care levels established by the participating institution.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any Major Morbidity/30-day Mortality
大体时间：within 30 days post surgery
|
a composite (any versus none) of the following major postoperative complications occurring:
|
within 30 days post surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post Operative Atrial Fibrillation
大体时间：15 - 30 days post operative
|
Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality.
Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery
|
15 - 30 days post operative
|
|
Duration of Hospitalization
大体时间：starting post operative day one to discharge from hospital, on an average of 8 days
|
Days from date of surgery to hospital discharge
|
starting post operative day one to discharge from hospital, on an average of 8 days
|
|
Duration of Intensive Care Stay
大体时间：ICU stay hours during hospital stay after surgery, on average of 25 hours
|
Hours from date of surgery to discharge from intensive care unit
|
ICU stay hours during hospital stay after surgery, on average of 25 hours
|
|
All-cause Mortality
大体时间：one year post operative
|
All-cause mortality identified during one-year follow-up.
|
one year post operative
|
|
a Composite of Minor Postoperative Complications
大体时间：within 30 days after surgery
|
a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.
|
within 30 days after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Daniel I Sessler, M.D.、The Cleveland Clinic
- 首席研究员：Andra I Duncan, M.D.、The Cleveland Clinic
- 首席研究员：Thomas Schricker, MD、Royal Victoria Hospital, Montreal, Canada
- 首席研究员：George Carvalho, MD、Royal Victoria Hospital, Montreal, Canada
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Albacker TB, Carvalho G, Schricker T, Lachapelle K. Myocardial protection during elective coronary artery bypass grafting using high-dose insulin therapy. Ann Thorac Surg. 2007 Dec;84(6):1920-7; discussion 1920-7. doi: 10.1016/j.athoracsur.2007.07.001.
- Duncan AE, Kateby Kashy B, Sarwar S, Singh A, Stenina-Adognravi O, Christoffersen S, Alfirevic A, Sale S, Yang D, Thomas JD, Gillinov M, Sessler DI. Hyperinsulinemic Normoglycemia Does Not Meaningfully Improve Myocardial Performance during Cardiac Surgery: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.
- Schricker T, Sato H, Beaudry T, Codere T, Hatzakorzian R, Pruessner JC. Intraoperative maintenance of normoglycemia with insulin and glucose preserves verbal learning after cardiac surgery. PLoS One. 2014 Jun 18;9(6):e99661. doi: 10.1371/journal.pone.0099661. eCollection 2014.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年7月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2007年8月31日
首先提交符合 QC 标准的
2007年8月31日
首次发布 (估计)
2007年9月3日
研究记录更新
最后更新发布 (实际的)
2018年10月26日
上次提交的符合 QC 标准的更新
2018年2月7日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.