NL-OMON49462
Withdrawn
Not Applicable
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 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medische Hulpmiddelen Industrie
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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