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Point and Trend Accuracy of a Continuous Glucose Measurement System using Intravenous Microdialysis in Critically Ill Patients


- candidate number17520
- NTR NumberNTR4527
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2014
- Secondary IDsNL47628.018.14 METC AMC
- Public TitlePoint and Trend Accuracy of a Continuous Glucose Measurement System using Intravenous Microdialysis in Critically Ill Patients
- Scientific TitlePoint and Trend Accuracy of a Continuous Glucose Measurement System using Intravenous Microdialysis in Critically Ill Patients
- ACRONYMACSI
- hypothesisThe primary objective of this study is to determine the point accuracy of a microdialysis–based continuous glucose monitoring system. Secondary objectives include trend accuracy and reliability of the system.
- Healt Condition(s) or Problem(s) studiedCritically ill patients, Blood glucose, Monitoring
- Inclusion criteria• At least 18 years old
• Arterial catheter needed for standard care present
• Central venous catheter needed for standard care
• Admitted to the ICU
• Expected to stay in the ICU for at least 48 hours
- Exclusion criteria• Currently participating in another investigational drug or device study; or
• Known pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-apr-2014
- planned closingdate22-apr-2015
- Target number of participants30
- InterventionsInsertion of the microdialysis system (EIRUSTM) into a central vein through a specialized central venous catheter (i.e., the specialized central venous catheter replaces the normally–used intravenous catheter). In blocks of 8 hours per day for a maximum of 3 days, every 15 minutes a reference blood glucose measurement is performed on blood taken from an existing arterial catheter.
- Primary outcomeThe main study parameter is point accuracy of continuous glucose monitoring–measurements as compared to current arterial blood glucose measurements.
- Secondary outcomeOther study parameters include trend accuracy and reliability of the system.
- TimepointsPatients will be monitored with the continuous glucose monitor for at most 72 hours. In blocks of 8 hours per day for a maximum of 3 days, every 15 minutes a reference blood glucose measurement is performed on blood taken from an existing arterial catheter.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIES J.H. Leopold
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Maquet
- Publications
- Brief summaryRationale: Insulin infusion in critically ill patients mandates frequent measurements of the blood glucose level. Several systems for continuous glucose monitoring have been developed, including systems that use microdialysis. Microdialysis is a well–established technology that offers the opportunity to sample blood analytes with high accuracy, but without drawing blood.

Objective: The primary objective of this study is to determine the point accuracy of a microdialysis–based continuous glucose monitoring system.
Secondary objectives include trend accuracy and reliability of the system.

Study design: This study concerns an investigator–initiated observational study in consecutive critically ill patients subjected to routine care–insulin infusion adjusted to reach blood glucose levels between 90 and 144 mg/dL (i.e., between 5 and 8 mmol/L).

Study population: Critically ill patients admitted to the Intensive Care Unit (ICU) of the Academic Medical Center at the University of Amsterdam, Amsterdam, The Netherlands.

Interventions (if applicable): Insertion of the microdialysis system (EIRUSTM) into a central vein through a specialized central venous catheter (i.e., the specialized central venous catheter replaces the normally–used intravenous catheter). In blocks of 8 hours per day for a maximum of 3 days, every 15 minutes a reference blood glucose measurement is performed on blood taken from an existing arterial catheter.
The microdialysis system: EIRUSTM is a continuous monitoring platform for glucose that has been adapted specifically for the needs of intensive care medicine. EIRUSTM offers continuous, second–by–second monitoring of the blood glucose level. Its multipurpose central venous catheter provides microdialysis monitoring, but also normal venous access.

Main study parameters/endpoints: The main study parameter is point accuracy of continuous glucose monitoring–measurements as compared to current arterial blood glucose measurements. Other study parameters include trend accuracy and reliability of the system.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The system has been tested and validated in a number of pre–clinical studies in non–ICU patients, and has been found to be safe and accurate in that setting. The device uses a special central venous catheter, which prevents the need for another central venous lines (i.e., the specialized central venous catheter replaces the normally–used intravenous catheter). Patients participating in this study are subjected to extra blood draws to a maximum of up to 12 ml over three days (i.e., a maximum of up to 4 ml per day), which is considered acceptable and safe. Patients could benefit from the study since continuous glucose monitoring could improve titration of insulin, in particular by preventing insulin–induced hypoglycemia.
- Main changes (audit trail)
- RECORD17-apr-2014 - 9-mei-2014


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