The purpose of this product development study is to carry out an assessment of the safety and performance of the GluCath System in patients admitted to the Intensive Care Unit (ICU). The GluCath System will be evaluated for up to 24 hours in ICU…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters will include reference analyzer blood glucose values,
GluCath System glucose values and duration of sensor use. Difference statistics
will include mean difference, standard deviation of the differences, mean
relative difference, and mean absolute relative difference, stratified by
glucose ranges.
Secondary outcome
Additional analyses will include the percentage of points compliant with
current and proposed accuracy standards (ISO 15197 and TNO Glucose Meters
Quality Standards) stratified by glucose ranges, Modified Bland-Altman plot
analysis and Clarke Error Grid analysis.
Background summary
Tight glycemic control is widely practiced in Intensive Care Units (ICU*s).
However, current glucose regulation regimens are time consuming because of the
need for frequent blood sampling, and still, hypoglycemia can occur in between
measurements. The answer to this problem is continuous glucose monitoring. In
the ICU most patients receive an intra-arterial catheter and the combination of
a glucose sensor into such a catheter would allow for continuous glucose
monitoring in arterial blood. This will inform physicians and nursing staff
better about the patient*s blood glucose levels, facilitating tight glucose
control.
Study objective
The purpose of this product development study is to carry out an assessment of
the safety and performance of the GluCath System in patients admitted to the
Intensive Care Unit (ICU). The GluCath System will be evaluated for up to 24
hours in ICU patients who meet the inclusion criteria for the study. Subjects
in the study will be hospitalized patients for whom glycemic control is
indicated.
Study design
Open-label trial
Study burden and risks
The study will be conducted on patients who will be admitted to the ICU
following elective cardiosurgical procedures. Informed consent will be obtained
beforehand. Patients will only be included if they are expected to have a
radial arterial catheter placed for invasive pressure monitoring or frequent
arterial blood sampling. This catheter will be used for the introduction of the
GluCath sensor. The number of arterial catheters will therefore not increase
with study participation. The volume of blood withdrawn from the patients will
be minimized by use of a Venous Arterial blood Management Protection (VAMP)
system (Edwards LifeSciences). Approximately 0.5 mL of blood per sample will be
discarded, for a maximum of 15 mL blood loss during the study.
Postbus 22660
1100DD Amsterdam
NL
Postbus 22660
1100DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age * 18 years;
Expected to be admitted to the ICU after elective cardiac surgery and expected to require glycemic control;
Expected to have a radial arterial catheter placed for invasive pressure monitoring or frequent arterial blood sampling;
Willing to have one GluCath sensor inserted by a health care professional through a standard radial artery catheter inserted either preoperatively or within six hours after admission to the ICU to provide routine care;
Willing to permit hourly arterial blood samples;
Exclusion criteria
An expected ICU stay of < 24 hours.
Known pregnancy;
A known contraindication to heparin;
Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., possibility that participation in the study would interfere with ongoing ICU care) or pose an excessive risk to study staff handling blood samples (e.g., known history of HIV, hepatitis B or C).
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL37102.018.11 |