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

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Status: Withdrawn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, 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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br><br /><br>To determine if the time in the desired glycemic range is equivalent by<br /><br>following the insulin infusion rate advice from the Glycostat algorithm<br /><br>compared to historical data in the ICU. The historical data for glycemic<br /><br>control includes at least 40 anonymous patients (with the same<br /><br>inclusion/exclusion criteria), which has been extracted extracted from EPIC<br /><br>(the hospital`s Healthcare Information System), or the NICE database and which<br /><br>has been analysed anonymously. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>There are no secondary study parameters.</p><br>

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