LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Glycemic Penalty Index (GPI) During the Intervention
研究概览
简要总结
The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients
详细描述
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
- Withdrawal of the informed consent
- Patient starts eating or drinking sugar containing liquids
- Patient is discharged from the ICU (including ICU deaths)
- Removal of arterial line or central venous line
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 (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
- •Aged 18 years or more
- •Admitted to the ICU
- •Already receiving or needing insulin infusion for blood glucose control
排除标准
- •Not critically ill (eating, not mechanically ventilated)
- •Pregnant or breastfeeding
- •Previous inclusion into the trial
- •Included in other trial
- •Diabetes coma
- •No arterial line available
研究组 & 干预措施
LOGIC-Insulin
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
干预措施: LOGIC-Insulin (Procedure)
Nurse-directed
Nurse-directed blood glucose control (80-110 mg/dL)
干预措施: Nurse directed (Procedure)
结局指标
主要结局
Glycemic Penalty Index (GPI) During the Intervention
时间窗: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.
The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control.
次要结局
- Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention(up to 14 days post-randomization)
- Hospital Mortality(up to 90 days post-randomization)
- Proportion of Patients With Common Hypoglycemia (<60 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)
- Interval Between Blood Glucose Measurements During the Intervention(up to 14 days post-randomization)
- Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention(up to 14 days post-randomization)
- Length of Stay in ICU(up to 90 days post-randomization)
- Length of Stay in Hospital(up to 90 days post-randomization)
- Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention(up to 14 days post-randomization)
- Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention(up to 14 days post-randomization)
- Hyperglycemic Index (HGI) During the Intervention(up to 14 days post-randomization)
- Daily Maximal Blood Glucose Difference During the Intervention(up to 14 days post-randomization)
研究者
Greet Van den Berghe
Head of Dept Intensive Care Medicine
KU Leuven