Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Short Insulin Tolerance Test (KITT)
研究概览
简要总结
Enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. Preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. While non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing CABG remains less understood. This study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.
详细描述
A randomized controlled trial comparing diabetic type 2 patients receiving carbohydrate loading with those undergoing traditional fasting protocols. Patients will be randomized to two groups; group (a) patients will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade), while group (b) patients (control group) will have standard fasting protocol 8 hours before surgery.
Aims of the study:
- To assess the efficacy of carbohydrate loading in reducing insulin resistance in diabetic type 2 patients undergoing CABG surgeries.
- To monitor clinical outcomes such as infection rates, ICU stay duration, and need for inotropic and vasoactive drugs.
- To evaluate changes in inflammatory markers including CRP levels. clinical outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.
排除标准
- •Missing data.
- •Patients outside the study period.
- •Patients undergoing other cardiac surgeries.
- •Patients diagnosed with type 1 diabetes mellitus.
研究组 & 干预措施
Intervention arm
Patients who will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)
干预措施: Carbohydrate loading before surgery (Dietary Supplement)
Control arm
Patients who will have standard fasting protocol 8 hours before surgery
结局指标
主要结局
Short Insulin Tolerance Test (KITT)
时间窗: Preoperatively and up to 72 hours postoperatively
Short Insulin Tolerance Test (KITT) will test changes in insulin tolerance postoperatively
次要结局
- CRP levels(Preoperatively and up to 72 hours postoperatively)
- Arterial blood gases(Preoperatively and up to 72 hours postoperatively)
- Operative time(Intraoperatively, skin-to-skin)
- CPB duration(Intraoperatively, using extracorporeal circulation)
- Blood loss(Intraoperatively and up to 72 hours postoperatively)
- Number of grafts performed(Intraoperatively, skin-to-skin)
- Use of inotrops(Intraoperatively and up to 72 hours postoperatively)
- Complications(Intraoperatively and up to 72 hours postoperatively)