Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients
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.
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.
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Styria
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Graz、Styria、奥地利、A8036
- Medical University Graz
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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1
Routine Care
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Dosing od insulin is calculated by a computer based algorithm
其他名称：
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2
Insulin infusion based on model predictive algorithm (MPC)
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Dosing od insulin is calculated by a computer based algorithm
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Time concentration profiles of arterial blood glucose concentrations and interstitial fluid glucose concentrations
大体时间：hourly
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hourly
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Prospectively calibrated interstitial fluid glucose concentration profiles
大体时间：hourly
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hourly
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合作者和调查者
调查人员
- 首席研究员：Thomas R. Pieber, MD、Medical University of Graz
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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