Mono-Centric, Open, Non-Controlled Study To Investigate The Feasibility Of Blood Glucose Control With The Software-Algorithm eMPC (Enhanced Model Predictive Control) In ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- percentage of time within the predefined glucose target range of 80-110 mg/dL
研究概览
简要总结
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.
In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age: > 18 years of age
- •Stay in the ICU expected to be > 120 h
- •Blood glucose > 110 mg/dl or patient on insulin treatment
排除标准
- •Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- •Known or suspected allergy to insulin
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- •Moribund patients likely to die within 24 hours
结局指标
主要结局
percentage of time within the predefined glucose target range of 80-110 mg/dL
时间窗: from start of treatment to the last glucose measurement under treatment
次要结局
- hypoglycemias (lab) and possible attendant clinical symptoms (e.g. convulsions)(from start of treatment to the last glucose measurement under treatment)
- Usability parameters like convenience of alarming function; workload; blood sampling frequency(from start of treatment to the last glucose measurement under treatment)
- Concomitant medication including insulin infusion rate, parenteral/enteral nutrition(from start of treatment to the last glucose measurement under treatment)