Glycemic control in the intensive care unit assisted by Glycostat, a continuos central venous blood glucose measurement system with an algorithm giving advice on insulin infusion rate - Glycemic control in the ICU assisted by Glycostat

Medische Hulpmiddelen Industrie0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•In order to be eligible to participate in this study, a subject must meet all
•of the following criteria:
•* Male and Female subjects, age * 18 years, * 85 years
•* ICU patients (any type) with an Arrow 3 or 4 lumen central venous catheter in
•place (CVC in situ not for study, but part of standard practice)
•* Clinical parameters (vital signs, medical history, and physical examination)
•not clinically significant or unstable as determined by the principal
•investigator.
•* Informed consent obtained before any activities related to the investigation

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•* Known or suspected allergy to device material
•* Not eligible to receive IV insulin
•* ICU patients without Arrow 3 lumen or 4 lumen central venous catheter in place
•* Previous participation (defined as participation on Day 1) in this trial.
•* Acute and/or severe chronic illness or history of any illness that, in the
•opinion of the Investigator, might pose additional risk in applying the
•Glycostat probe to the subject
•* Participation in another investigational study within 30 days prior to
•investigation start
•* Surgery or trauma with significant blood loss within the last 2 months prior
•to application of the micro dialysis probe
•* Subject with mental incapacity or language barriers precluding adequate
•understanding or co operation, who is unwilling to participate in the study or
•who, in the opinion of the Investigator, should not participate in the study.

发起方

Medische Hulpmiddelen Industrie