跳至主要内容
临床试验/NCT02296372
NCT02296372已完成不适用

Pilot Observation of Continuous Glucose Monitoring in Critically Ill Patients Under Consideration of Accuracy, Feasibility and Acceptance by Ward Staff

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Accuracy of continuous glucose monitoring compared to blood gas analyses

研究概览

简要总结

Critically ill patients are on high risk for increased serum glucose levels, leading to more comorbidity and higher mortality risk. In patients with severe sepsis and septic shock hyperglycemia is a typical finding. However the need of insulin therapy is associated with an increased risk of hypoglycemia. Newly developed technologies for continuous glucose monitoring in critically ill patients may improve glycemic control and reduce glucose variability. The investigators will perform continuous glucose monitoring in critically ill patients on ICU. Measurements will be done for a period of 72h per patient. The investigators aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to arterial blood gas measurements with the blood gas analyzer. The investigators will investigate the influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a questionnaire to identify acceptance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
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

  • •critically ill patients with expected ICU stay for more than 72 hours
  • •informed consent by the patients or legal proxy

排除标准

  • •age < 18
  • •no informed consent by the patients or legal proxy
  • •pregnancy
  • •infaust prognosis

研究组 & 干预措施

SOFA <7

Other

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement.

Intervention: Measuring continuous glucose monitoring.

干预措施: Continuous glucose monitoring (Device)

SOFA >7

Other

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement.

Intervention: Measuring continuous glucose monitoring.

干预措施: Continuous glucose monitoring (Device)

结局指标

主要结局

Accuracy of continuous glucose monitoring compared to blood gas analyses

时间窗: 72 hours

Difference between glucose values of continuous glucose monitoring and blood gas analyses

次要结局

  • Feasibility of continuous glucose monitoring(72 hours)
  • Acceptance of continuous glucose monitoring by physicians and nursing staff(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffen Weber-Carstens

PD Dr. med. Steffen Weber-Carstens

Charite University, Berlin, Germany

研究点 (1)

Loading locations...

相似试验