Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period
研究概览
简要总结
This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.
详细描述
Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-diabetes mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia. The main goals of this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery.
To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress, obese patients without diabetes mellitus undergoing CABG surgery will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 40 and 80 years
- •Body mass index (BMI) ≥25
- •Undergoing elective CABG surgery
- •No previous history of diabetes or hyperglycemia
排除标准
- •Hyperglycemia (BG>125 mg/dl or HbA1c > 6.5%) or previous treatment with antidiabetic agents
- •Impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
- •Gastrointestinal obstruction expected to require gastrointestinal suction
- •Patients with clinically relevant pancreatic or gallbladder disease
- •Treatment with oral or injectable corticosteroid
- •Mental condition rendering the subject unable to understand the possible consequences of the study
- •Pregnancy or breastfeeding at time of enrollment
研究组 & 干预措施
Dulaglutide Arm
Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.
干预措施: Dulaglutide Injection (Drug)
Placebo Arm
Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.
干预措施: Saline Injection (Other)
结局指标
主要结局
Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period
时间窗: During the hospital stay (up to 12 days postoperatively)
Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
次要结局
- Number of Participants Experiencing Hypoglycemic Events(During the hospital stay (up to 12 days postoperatively))
- Number of ICU Readmissions(During the hospital stay (up to 12 days postoperatively))
- Mean Insulin Dose Per Day While in the ICU(During the ICU stay (up to 7 days postoperatively))
- Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively(During the ICU stay (up to 7 days postoperatively))
- Number of Participants Needing CII Treatment in the ICU(During the ICU stay (up to 7 days postoperatively))
- Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII(During the hospital stay (up to 12 days postoperatively))
- Days of Subcutaneous (SC) Insulin After Discontinuation of CII(During the hospital stay (up to 12 days postoperatively))
- Number of Participants Experiencing Hyperglycemic Events(During the hospital stay (up to 12 days postoperatively))
- Mean Blood Glucose Levels During the Hospital Stay(During the hospital stay (up to 12 days postoperatively))
- Mean Units Per Hour of Insulin While in the ICU(During the ICU stay (up to 7 days postoperatively))
- Number of Participants Experiencing Gastrointestinal Adverse Events(During the hospital stay (up to 12 days postoperatively))
- Number of Participants Experiencing Mortality and Complications(During the hospital stay (up to 12 days postoperatively))
- ICU Length of Stay(During the ICU stay (up to 7 days postoperatively))
- Hospital Length of Stay(During the hospital stay (up to 12 days postoperatively))
- Number of Cerebrovascular Events(During the hospital stay (up to 12 days postoperatively))
- Participant Mortality(During the hospital stay (up to 12 days postoperatively))
- Duration of Continuous Insulin Infusion (CII)(During the hospital stay (up to 12 days postoperatively))
- Amount of SC Insulin Administered(During the hospital stay (up to 12 days postoperatively))
研究者
Francisco Pasquel
Associate Professor
Emory University