Intensive care - Glycemic control in the ICU Hyperglycemia Hypoglyceamia
Conditions
Interventions
None listed
Sponsors
Medische Hulpmiddelen Industrie
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To verify the accuracy and performance of the GlycostatTM System including its ability to secure good glycemic control by means of its algorithm. The accuracy of Glycostat, expressed by MARD (Mean Absolute Relative Difference), the mean average of the relative deviation to the reference (Blood gas measurement) is to be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): To determine if the time in the desired glycemic range is improved by following the insulininfusion rate advice from the Glycostat algorithm compared to a control group in which the normal practice of the ICU is followed. The control group data come from historical data on glycemic control of at least 40 patients extracted from EPIC the hospital`s Healthcare Information System. | — |
Countries
Netherlands
Outcome results
None listed