The Effect of Intraoperative Tight Glycemic Control on Surgical Site Infection Rates in Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection
研究概览
简要总结
The purpose of this study was to investigate the effects of three different glycemic treatment conditions (tight, conventional, and standard) in the intraoperative period on: 1) postoperative surgical site infections, and 2) postoperative procalcitonin, and C-reactive protein levels in patients undergoing open-heart surgery. Secondary aims of the study were to investigate the effects of the three glycemic treatment conditions on: 1) intraoperative blood glucose; 2) intraoperative glycemic stability; and 3) intensive care unit length of stay, in patients undergoing open-heart surgery.
详细描述
An experimental design with a multilevel, single factor, within-subjects design was utilized. Patients were nested within anesthesia provider teams. The design was counterbalanced by means of a Latin square, where each of three anesthesia provider teams dispensed each of three glycemic treatment conditions once.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over the age of 21
- •on cardiopulmonary bypass or off cardiopulmonary
- •elective or urgent coronary artery bypass graft (CABG) surgery
- •CABG with or without combined valve surgery
- •valve surgery
排除标准
- •chronically immunosuppressed
- •suffered from end-stage organ disease
- •currently had active infections
- •underwent emergent or salvage CABG surgery
- •had an implanted insulin pump
- •were in another interventional clinical trial.
研究组 & 干预措施
Tight Glycemic Group
The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.
干预措施: Tight Glycemic (Drug)
Conventional Glycemic Group
The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
干预措施: Conventional Glycemic (Drug)
Standard Glycemic Group
The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.
干预措施: Standard Glycemic (Drug)
结局指标
主要结局
Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection
时间窗: six weeks postoperatively
The presence or absence of deep, or/and superficial sternal wound infection and deep, superficial harvest site infection within in six weeks postoperatively was a primary outcome variable. Infection assessment was performed during the intensive care phase, at hospital discharge, two-week post hospital discharge and six-week post hospital discharge by independent blinded researchers that were part of the cardiothoracic team.
The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery
时间窗: Post CPB and Postoperative days 1 through 5
Procalcitonin concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All procalcitonin blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean procalcitonin values with standard deviation.
The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery
时间窗: Post cardiopulmonary bypass and postoperative day 1 through 5
C-Reactive Protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All C-Reactive Protein blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean C-Reactive Protein values with standard deviation.
次要结局
- The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery(ICU days measured every day the patient stayed in ICU starting with entry into the ICU from the Operating Room until discharge from the ICU to the ward)
- Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery(Blood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred first)
- Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.(Measures of blood glucose every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes whichever event occurred first)
研究者
Sierra Gower
Dr.
James A. Haley Veterans Administration Hospital