Randomised Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Microdialysis Glucose Monitoring in Post Surgery Patients at the Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations
研究概览
简要总结
The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.
It is the aim of this study to evaluate the correlation between arterial blood glucose concentrations and interstitial fluid glucose concentrations in post surgery patients in the Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on microdialysis in subcutaneous adipose tissue and calculated using the ionic reference technique.
详细描述
This trial includes a screening visit (V1) and a monitoring visit (V2) and follow-up assessment. Visit 1 will be performed before performance of surgery to obtain informed consent and to assess patient eligibility. At Visit 2 monitoring visit after surgery) arterial blood glucose values will be monitored and subcutaneous sampling of ISF with microdialysis for glucose determination will be performed. Visit 2 will last from admittance to the ICU for 48 hours. In a follow-up assessment, two weeks after the end of visit 2, further clinical relevant data for the two week period after visit 2 will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained before any trial-related activities.
- •Planned surgery and post-surgery stay in the ICU.
- •Study day inclusion criteria: Increased blood glucose levels at admission to the ICU ( > 120 mg/dL; > 6.7 mM)
- •Age of patients in the range from 18 to 90 years.
排除标准
- •Known or suspected allergy against insulins.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- •Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
研究组 & 干预措施
1
Routine Care
干预措施: dosing of insulin (Drug)
2
Insulin infusion based on model predictive algorithm (MPC)
干预措施: dosing of insulin (Drug)
结局指标
主要结局
Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations
时间窗: hourly
次要结局
- Prospectively calibrated interstitial fluid glucose concentration profiles(hourly)