PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Median glucose
研究概览
简要总结
The incidence of diabetes mellitus type II is increasing. More and more patients who need surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia. There is no evidence for the optimal glucose lowering protocol.
This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.
详细描述
Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment. Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in low incidence of hypoglycaemia. This study investigates for the first time the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus undergoing non-cardiac surgery.
Objective
This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •known diabetes mellitus type II for > 3 months
- •aged 18-75 years
- •scheduled for elective non-cardiac surgery
排除标准
- •Daily insulin dosage of > 1 IU/kg body weight
- •Oral corticosteroid use
- •Planned for day-care (ambulant) surgery
- •Planned ICU stay post-operatively
- •Planned bowel surgery
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Impaired renal function defined as serum-creatinine ≥ 133 μmol/L for males and ≥ 115 μmol/L for females
- •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- •Known or suspected allergy to trial product(s) or related products
- •Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
研究组 & 干预措施
BR (bolus regimen)
-
Day before surgery: half evening dose long acting insulin
-
Day of surgery:
-
patients using mealtime and longacting insulin/NPH: withhold mealtime morning dose, stop glucose lowering tablets
-
patients using only long acting insulin/NPH: half dose of long-acting or NPH insulin, stop glucose lowering tablets
-
Measure blood glucose every 60 minutes, start 30 min prior to surgery
-
Give bolus of insulin according to treatment algorithm
干预措施: Insulin bolus (Drug)
LG (Liraglutide)
- Day before surgery: half dose of long acting and mealtime insulin from start liraglutide
- Day of surgery: withhold own insulin, stop oral glucose lowering tablets
- Start with 0.6 mg liraglutide subcutaneously (s.c.) the day prior to surgery at 17.00hr.
- In case of nausea graded higher than minimal, the patient will be excluded from the study
- Otherwise, treatment will be continued with 1.2 mg liraglutide s.c. per day on the day of surgery at 07.00hr.
- Measure glucose every 60 minutes, start 30 min prior to surgery
- Adjust according to bolus algorithm of BR group
干预措施: Liraglutide (Drug)
LG (Liraglutide)
- Day before surgery: half dose of long acting and mealtime insulin from start liraglutide
- Day of surgery: withhold own insulin, stop oral glucose lowering tablets
- Start with 0.6 mg liraglutide subcutaneously (s.c.) the day prior to surgery at 17.00hr.
- In case of nausea graded higher than minimal, the patient will be excluded from the study
- Otherwise, treatment will be continued with 1.2 mg liraglutide s.c. per day on the day of surgery at 07.00hr.
- Measure glucose every 60 minutes, start 30 min prior to surgery
- Adjust according to bolus algorithm of BR group
干预措施: Insulin bolus (Drug)
GIK (glucose -insulin - potassium) infusion
- Day before surgery: half evening dose long acting insulin
- Day of surgery: stop oral glucose lowering tablets and withhold own insulin.
- GIK infusion: 500 cc glucose 5% with insulin and 10 mmol KCL per 500 cc. Start at 83 ml/hr.
- Calculate the insulin amount in the GIK infusion according to the formula:
I= (PG-7)/(200/W)+8 I=Insulin amount, PG=glucose 30 minutes preoperative, W= body weight in kg
- Measure blood glucose every 60 minutes, start 30 min prior to surgery
- Adjust glucose > 8 mmol/l according to treatment algorithm
干预措施: GIK infusion (Drug)
结局指标
主要结局
Median glucose
时间窗: 1 hour after surgery
The difference in median glucose between the GIK + BR and LG group 1 hour after surgery
次要结局
- Median glucose(4 hours and 1 day postoperative)
- Postoperative complications(1 month after surgery)
- Hypo- and hyperkalemia(from start treatment until morning of day 1 postoperative)
- Hypoglycemia(From start treatment until the morning of day 1 postoperative)
- Total Insulin administration(1 day postoperative)
- Glucose(From start treatment until morning of day 1 postoperative)
研究者
B Preckel
Prof dr B Preckel, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)