NL-OMON55181撤回不适用
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:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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, 4 or 5 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
- •from the patient or their legal representative
- •Require IV infusion of insulin to control their blood glucose level
排除标准
- •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 or 5 lumen central venous catheter in
- •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.
- •In case a legal representative receives the patient information and provides
- •the patient consent the subject may be in included.
- •Patients unwilling to participate
研究者
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