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,
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 or 5 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. In case a legal representative receives the patient information and provides the patient consent the subject may be in included. • Patients unwilling to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To determine if the time in the desired glycemic range is equivalent by following the insulin infusion rate advice from the Glycostat algorithm compared to historical data in the ICU. The historical data for glycemic control includes at least 40 anonymous patients (with the same inclusion/exclusion criteria), which has been extracted extracted from EPIC (the hospital`s Healthcare Information System), or the NICE database and which has been analysed anonymously. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary study parameters. | — |
Countries
Netherlands
Outcome results
None listed