LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 1,550
- 试验地点
- 4
- 主要终点
- Glycemic Penalty Index (GPI) during the Intervention
研究概览
简要总结
Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the ICU with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line
- •Patients should be 18 years or older
排除标准
- •Not critically ill
- •Age under 18 years
- •Patients already enrolled in another intervention randomized controlled trial
- •Patients expected to die within 12 hours (=moribund patients)
- •No arterial line or central venous line needed
- •Pregnancy or lactating
- •Patients suffering from ketoacidotic or hyperosmolar coma on admission
- •Patients who have been previously been included in the LOGIC-2 study
- •Allergy to insulin
研究组 & 干预措施
Nurse-directed
Blood glucose control guided by paper protocol
干预措施: Paper protocol (Device)
LOGIC-Insulin
Blood glucose control guided by the LOGIC-Insulin algorithm
干预措施: LOGIC-Insulin algorithm (Device)
结局指标
主要结局
Glycemic Penalty Index (GPI) during the Intervention
时间窗: up to 14 days post-randomization
Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)
次要结局
- Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention(up to 14 days post-randomization)
- Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention(up to 14 days post-randomization)
- Blood Glucose Level Per Treatment Group during the Intervention(up to 14 days post-randomization)
- Hyperglycaemic index (HGI)(up to 14 days post-randomization)
- Time in target range(up to 14 days post-randomization)
- Time to target range(up to 14 days post-randomization)
- Daily maximal blood glucose difference(up to 14 days post-randomization)
- Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention(up to 14 days post-randomization)
- Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention(up to 14 days post-randomization)
- Interval between blood glucose measurements(up to 14 days post-randomization)
- Protocol compliance in the intervention group(up to 14 days post-randomization)
- Overrules in the intervention group(up to 14 days post-randomization)
- Incidence of new infections in the ICU(up to 90 days post-randomization)
- Mortality in the hospital(up to 90 days post-randomization)
- Landmark 90-day mortality(up to 90 days post-randomization)
- All direct medical costs from a healthcare payer's perspective(up to 90 days post-randomization)
- Quality of Life(up to 90 days post-randomization)
- Length of stay in the ICU(up to 90 days post-randomization)
- Length of stay in the hospital(up to 90 days post-randomization)
- Mortality in the ICU(up to 90 days post-randomization)