Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 主要终点
- index GLI (Glycemic Lability Index)
研究概览
简要总结
This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under postoperative intensive care
- •Treatment with insulin on bi-lumen central venous catheter over than 48 hours
- •Eligibility for interstitial glucose monitoring
- •Blood glucose control every 3 hours
排除标准
- •Pregnant or breastfeeding women
- •Patient unwilling to participate in the study
- •Patients participating in another study biomedical over the same period
- •Patient can not understand the study and its objectives
- •Patient under guardianship, curatorship
- •Patient malnourished (BMI <18 kg / m²)
- •Patient with morbid obesity (BMI> 40 kg / m²)
- •Patient in shock (septic or hemodynamic)
- •Patients refusing to sign the Medtronic consent on the storage of personal data
研究组 & 干预措施
Standard infusion line
The standard insulin infusion system consisted in regular human insulin administration through a six-stopcock manifold connected to the distal line of a multilumen central venous catheter by 150 cm tubing. Insulin was systematically infused by syringe pump on the patient proximal port of the manifold. Carrier was infused via pump through the manifold. All others medicines were infused through the other five stopcocks.
干预措施: Standard infusion line (Device)
Optimised infusion line
The optimised insulin infusion system consisted in regular human insulin administration through a multilumen device (Edelvaiss Multiline-8, Doran International, Toussieu, France). This device had ports for eight infusions which run through separate channels within a 150 cm flexible plastic tube. Since fluids from the individual channels do not meet until they exit the distal tip. Carrier was infused through the high flow (HF) line and insulin was infused by syringe pump systematically next to the HF line port. All others medicines were administered via adjacent ports on the Multiline-8.
干预措施: Edelvaiss Multiline-8 (Device)
结局指标
主要结局
index GLI (Glycemic Lability Index)
时间窗: up to 48 hours
This index is calculated from capillary blood glucose.
次要结局
- Sequential Organ Failure Assessment score (SOFA)(during the 4 days of hospitalization period)
- Mean Amplitude Glycemic Excusions score (MAGE)(every 3 hours during 48 hours)
- standard deviation of blood glucose(every 3 hours during 48 hours)
- length of stay in Intensive Care Unit (ICU) or in hospital(during the 4 days of hospitalization period)
- Death rate(during the 4 days of hospitalization period)
- average blood glucose(every 3 hours during 48 hours)
- Number of hypoglycaemic events(48 hours)
- Number of hyperglycaemic events(48 hours)