PREOPERATIVE ORAL CARBOHYDRATE LOADING: EFFECTS ON THE GLUCOSE METABOLISM AND POSTOPERATIVE INFECTIONS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 880
- 试验地点
- 2
- 主要终点
- rate of postoperative complications
研究概览
简要总结
Postoperative infectious morbidity remain the most frequent, threatening and costly event after major surgery. Maintenance of postoperative euglycemia might be a key factor to prevent such complications and given the preliminary data on the positive effect of carbohydrate load on glucose metabolism it might also be valuable in improving outcome. If this treatment will be proved effective on relevant outcome measure such as rate of infections, it might be used routinely and extensively because preoperative carbohydrates administration is cheap, simple and applicable by everyone in any surgical ward.
The aim of the trial is to evaluate if the normalization of blood glucose by means of preoperative oral administration of maltodextrine, in patients candidate to elective major surgery, may be effective in improve surgical morbidity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients candidate for elective major (expected duration > 2 hrs) abdominal, urologic, and gynecologic surgery
排除标准
- •diagnosis of diabetes mellitus,
- •baseline plasma glucose level > 125 mg/dl,
- •pancreatic resection,
- •ASA score > 3,
- •malnutrition (loss of weight greater than 10%),
- •emergency surgery,
- •documented gastro-esophageal reflux,
- •corticosteroid therapy,
- •ongoing infection,
- •pregnancy,
- •age < 18 years,
- •denied written informed consent
结局指标
主要结局
rate of postoperative complications
时间窗: 30 days
次要结局
- length of hospital stay(15 days)
- rate of patients needing intensive care treatment(15 days)
- rate of patients needing insulin treatment(4 days)
- rate of total complications(30 day after surgery)
- rate of patients needing antibiotic therapy(30 days after surgery)
- rate of reopaeration(15 days)
研究者
Luca Vittorio Gianotti
professor of surgery
University of Milano Bicocca