Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
研究概览
简要总结
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
详细描述
High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.
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 (Participant)
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
- •diabetes mellitus
- •post-cardiothoracic surgery
- •requiring an insulin infusion of at least 1 unit/hour
- •Age 18-75
排除标准
- •Glucocorticoids
- •total parenteral nutrition (TPN) or tube feeds
- •Pregnancy
- •Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
- •Expected length of stay less than 48 hours following cessation of the insulin drip
- •Patients using subcutaneous insulin pumps
- •Diabetic ketoacidosis
- •End-stage renal disease
- •End-stage liver disease
- •Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
- •Unable to give consent in English
研究组 & 干预措施
1
Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
干预措施: Detemir (Drug)
2
Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
干预措施: Detemir (Drug)
3
Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
干预措施: Detemir (Drug)
结局指标
主要结局
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
时间窗: day 2, day 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
次要结局
- Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)(48 hours)
- Reversion to Intravenous Insulin for Failure of Glycemic Control(72 hours)
研究者
Kathleen Dungan
Assistant Professor of Medicine
Ohio State University