NCT03890432已完成不适用
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study
HEIDEGGER CP4 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2023年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 4
- 主要终点
- Time-in-target (range: 5.0 - 8.5 mmol/l)
研究概览
简要总结
The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2 software, developed by the model-based medical decision support of Aalborg University (Denmark) and adapted to the clinical needs in the intensive care unit (ICU) of the Geneva University Hospital (HUG). This new device is based on a mathematical model of the glucose-insulin metabolism and attempts to give advices for better glycaemia control and nutritional therapy. The GLUCOSAFE 2 study hypothesizes that the use of the Glucosafe 2 software will allow better glycaemia ("Time-in-target") control and better achievement of nutritional energy and protein targets in comparison to the local protocols.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ≥ 18 years admitted to the ICU with
- •An expected length of stay ≥ 72h
- •At least 1 blood glucose (BG) measurement ≥10 mmol/l or 2 BG measurement ≥ 8.5 mmol/l
- •Informed Consent signed by the subject/ legal representative, except for patients in the historical control group
排除标准
- •Lack of legal consent or consent withdrawn, except for patients in the historical control group
- •Pregnant or breast feeding
- •Diabetic ketoacidosis or hyperosmolar state
- •Oral feeding
- •Fulminant hepatic failure
- •Medically contraindicated to receive rapidly acting insulin by intravenous (iv) infusion or iv injection
结局指标
主要结局
Time-in-target (range: 5.0 - 8.5 mmol/l)
时间窗: During ICU stay, up to 15 days post-randomization.
Time spent in the glycaemia range of 5.0 - 8.5 mmol/l per day, per patient and in the cohort
次要结局
- Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance(During ICU stay, up to 15 days post-randomization.)
- Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)(During ICU stay, up to 15 days post-randomization.)
- Time to normalize blood glucose (5.0-8.5 mmol/l)(During ICU stay, up to 15 days post-randomization.)
- Frequency of daily and cumulated BG measurements per patient and in the cohort(During ICU stay, up to 15 days post-randomization.)
- Glycaemic variability(During ICU stay, up to 15 days post-randomization.)
- Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance(During ICU stay, up to 15 days post-randomization.)
- Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance(During ICU stay, up to 15 days post-randomization.)
- Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)(During ICU stay, up to 15 days post-randomization.)
- Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance(From normalization time during ICU stay, up to 15 days post-randomization.)
- Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.(During ICU stay, up to 15 days post-randomization.)
- Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.(During ICU stay, up to 15 days post-randomization.)
- Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)(During ICU stay, up to 15 days post-randomization.)
- Prediction of BG(During ICU stay, up to 15 days post-randomization.)
- Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events(During ICU stay, up to 15 days post-randomization.)
- Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)(From normalization time during ICU stay, up to 15 days post-randomization.)
- Number of episodes (per patient and in the cohort) where a BG measurements is not followed up within 30 minutes by a request for Glucosafe 2 advice(During ICU stay, up to 15 days post-randomization.)
- Number of episodes (per patient and in the cohort) where pumps were not set within 30 min according to Glucosafe2 advice accepted by the nurse.(During ICU stay, up to 15 days post-randomization.)
- Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received(During ICU stay, up to 15 days post-randomization.)
- Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events(During ICU stay, up to 15 days post-randomization.)
- Number of advices given by GS2 which were accepted, accepted with modification, or rejected.(During ICU stay, up to 15 days post-randomization.)
研究者
HEIDEGGER CP
Privat-Docent, Senior Lecturer
University Hospital, Geneva
研究点 (4)
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