Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Number of days at home after surgery (DAH-30).
研究概览
简要总结
Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.
There are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.
详细描述
Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).
Consequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. The study hypothesis is that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).
The current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% [≥58 mmol/mol]) for reducing postoperative morbidity and mortality.
The patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:
- Short-term glycemic control group:
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.
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 adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is > 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).
排除标准
- •Patients < 18 years
- •Emergency Surgery
- •Elective surgery that can be postponed safely till glycemic control
- •Hb A1c < 7.5%
- •Pregnant patients
- •Patient Refusal
研究组 & 干预措施
Standard-of-care group
Patients will be admitted the day before surgery with the usual patient treatment.
干预措施: Standard-of-care group (Other)
Short-term glycemic control group
Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed.
干预措施: Short-term glycemic control group (Other)
结局指标
主要结局
Number of days at home after surgery (DAH-30).
时间窗: 30 days after surgery
Continuous outcome as the number of days over the 30 days after surgery.
次要结局
- Quality of Recovery15 (QoR-15)(after 24 hours of surgery)
- Loss of follow-up after surgery(30 days after Surgery)
- Length of hospital stay(30 days after surgery)
- Loss of follow up after the clinic preoperative assessment(30 days after initial assessment)
- 30-day mortality(30 days after surgery)
- incidence of postoperative complications(30 days after surgery)