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

Withdrawn

Conditions: Intensive care - Glycemic control in the ICU
Hyperglycemia
Hypoglyceamia

Registration Number: NL-OMON49462

Lead Sponsor: Medische Hulpmiddelen Industrie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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
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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br><br /><br>To verify the accuracy and performance of the GlycostatTM System including its<br /><br>ability to secure good glycemic control by means of its algorithm. The accuracy<br /><br>of Glycostat, expressed by MARD (Mean Absolute Relative Difference), the mean<br /><br>average of the relative deviation to the reference (Blood gas measurement) is<br /><br>to be determined.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br><br /><br>To determine if the time in the desired glycemic range is improved by following<br /><br>the insulininfusion rate advice from the Glycostat algorithm compared to a<br /><br>control group in which the normal practice of the ICU is followed. The control<br /><br>group data come from historical data on glycemic control of at least 40<br /><br>patients extracted from EPIC the hospital`s Healthcare Information System. </p><br>