Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- 30-day all-cause mortality.
研究概览
简要总结
Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units.
We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.
详细描述
Current evidence supports intensive glucose control for patients in the intensive care unit post-cardiac surgery. The risk-benefit ratio of tight glucose control using continuous insulin infusion during surgery has not been established. Pros for tight control include the association of hyperglycemia with neurological injury, cardiac ischemia, white blood cell dysfunction and renal failure. The cons include adverse effects, mainly hypoglycemia and hypokalemia. As with any intervention in medicine, tight intra-operative glucose control should be assessed in a randomized controlled trial.
Objectives:to assess whether tight intra-operative tight glucose control using continuous insulin infusion reduces morbidity and mortality following cardiac surgery, defined as the incidence rate of surgical site infections, adverse neurological events, renal failure and 30-day mortality following CABG.
Additional outcomes will include the effect of continuous insulin infusion on longer-term mortality; other infectious complications and antibiotic use during hospitalization; cardiovascular outcomes; the need for re-operations; length of hospital stay; readmission; hypoglycemia and other adverse events.
Design: randomized controlled trial, with blinding of outcome assessors.
Participants: all consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
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
- None
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
- •All consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
排除标准
- •Patients with diabetic ketoacidosis, or hyperosmolar coma
研究组 & 干预措施
1
Intervention
干预措施: Intraoperative continuous insulin infusion (Drug)
2
Control
干预措施: Control (Other)
结局指标
主要结局
30-day all-cause mortality.
时间窗: 30-day
Deep or organ/ space (mediastinitis) surgical site infections.
时间窗: 90 days
Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy.
时间窗: 30 days
Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit.
时间窗: 30 days
次要结局
- Individual components of the composite primary outcome(30 days)
- Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria(ICU stay)
- Other post-operative complications occurring during ICU stay, including re-intubation, re-operation(ICU stay)
- Occurrence of hypoglycemia, defined as blood glucose level of 50mg/ dl or less, during surgery and up to the first glucose measurement in ICU.(during surgery)
- Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery(during surgery)
- 6-months and long-term survival.(6 ans 12 months)
- Durations of intubation, ICU and hospital stay(hospital stay)
- Antibiotic use(30 days)
- Glucose control in ICU, during the first 2 post-operative days(2 post-operative days)
- Neurological status before surgery, at discharge and 3 months following surgery:(3 months)
- Adverse cardiac events occurring during ICU stay(ICU stay)
- Re-hospitalizations(30 days)