Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 主要终点
- Incidence of Perioperative Hyperglycemia
研究概览
简要总结
Evaluation of the effect of peri-operative continuation of oral metformin therapy on the incidence of perioperative hyperglycemia compared to standard preoperative cessation of oral metformin therapy 24h before surgery.
详细描述
Surgical procedures cause metabolic stress and can impair glucose control especially in patients with diabetes mellitus, which often results in peri-operative hyperglycemia. Peri-operative hyperglycemia is associated with impaired wound healing, secondary wound infections, endothelial dysfunction, sepsis, prolonged hospital stay and higher mortality.
Metformin is still the first line treatment in patients with type 2 diabetes mellitus.
Historically it has been stopped before surgery due to fear of hypoglycemia and metformin induced lactic acidosis. However recent studies have suggested that perioperative continuation of metformin might be safe and patients could benefit from more stable preoperative blood sugar levels.
Prospective studies evaluating the benefit of continuing oral metformin therapy in the perioperative period are rare.
The investigators plan to conduct a prospective, randomized-controlled, unblinded clinical trial where patients with type II diabetes mellitus and oral metformin therapy undergoing non-cardiac surgery will be randomized in either an interventional group or a control group. In the interventional group patients will be instructed to continue their regular metformin dose even on the day of surgery, in contrast to the control group, where the patients will be instructed to stop taking metformin 24h prior to surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-99 years
- •Diabetes Mellitus Typ 2
- •Oral metformin therapy
- •Non cardiac-surgery
- •Informed consent
排除标准
- •Insulin therapy
- •Ambulatory surgery
- •Preoperative therapy with glucocorticoids (prednisolon or equivalent ≥ 5mg/day for more than 7 days)
- •Planned postoperative ICU-stay
- •Advanced renal insufficiency (eGFR < 45ml/kg/min)
- •Advanced liver cirrhosis or failure (Child-Pugh B or C)
- •Alcohol abuse
- •Pregnancy,
- •Perioperative administration of contrast dye
研究组 & 干预措施
Metformin +
The study intervention involves the self-administration of metformin in the same dosage as the patient's regular dosage according to regular dosing schedule and randomization.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Incidence of Perioperative Hyperglycemia
时间窗: 24 hours pre-op until 24 hours post-op
blood glucose \>180mg/dl (10mmol/l) and/or necessity of additive administration of insulin s.c. during the time frame
次要结局
- Mortality(up to 4 weeks)
- Incidence hypoglycemia(24 hours pre-op until 24 hours post-op)
- Perioperative blood glucose control(24 hours pre-op until 24 hours post-op)
- Perioperative lactate levels(24 hours pre-op until 24 hours post-op)
- Incidence of hyperlactatemia(24 hours pre-op until 24 hours post-op)
- Perioperative renal function(24 hours pre-op until 24 hours post-op)
- Hospitalization Duration(up to 4 weeks)
研究者
Jens Meier
Prof. Jens Meier, MD
Kepler University Hospital