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Study to assess the accuracy of two continuous glucose monitors in relation to the microcirculatory function at the adult intensive care.


- candidate number5678
- NTR NumberNTR1790
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2009
- Secondary IDsR-08.35O VCMO Nieuwegein
- Public TitleStudy to assess the accuracy of two continuous glucose monitors in relation to the microcirculatory function at the adult intensive care.
- Scientific TitleTissue oxygenation and perfusion and the determination of glucose subcutaneously.
- ACRONYMTOP DOGS
- hypothesisThe most severely ill patients have the poorest peripheral tissue perfusion and oxygenation, which will negatively influence the accuracy of continuous glucose monitoring measurements.
- Healt Condition(s) or Problem(s) studiedContinuous glucose monitoring, Cardiothoracic surgery
- Inclusion criteria1. Admission to the hospital for elective open cardiac surgery (coronaty artery bypass graftl mitral-, tricuspidal- and aortic valve surgery);
2. Age 18-85 years;
3. Willing and able to give written informed consent.
- Exclusion criteriaAbdominal abnormalities that inhibit sensor insertion.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 3-jun-2009
- planned closingdate31-dec-2009
- Target number of participants60
- InterventionsN/A
- Primary outcomeDifference in glucose values (mmol/l) measured by the two CGMs, Guardian RT and FreeStyle Navigator, compared to 'gold standard' blood glucose values measured by the Accu-Chek Compact Plus (mmol/l), expressed as mean absolute difference (MAD) of glucose values.
- Secondary outcome1. Microcirculatory function expressed as % of perfused vessels as measured by OPS;
2. Microcirculatory function expressed as microvascular flow index (MFI) as measured by OPS;
3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to total haemoglobin as measured by near infrared spectroscopy (NIRS);
4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse oximetry;
5. APACHE II score;
6. SOFA score.
- Timepoints1. Continuous glucose monitoring for 72 hours by the Guardian RT and FreeStyle Navigator starting preoperative;
2. 'Gold standard' blood glucose values measured by the Accu-Chek Compact Plus measured every 2 hours;
3. Microcirculatory function measured by orthogonal polarization spectometry (OPS) every 6 hours;
4.Tissue oxygenation saturation measured by near infrared spectroscopy (NIRS) assessed continuously during ICU stay.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD S.E. Siegelaar
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Vries, de
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
European Foundation for the study of Diabetes (EFSD)
- PublicationsN/A
- Brief summaryStudy to assess the accuracy of two continuous glucose monitors (Guardian RT and FreeStyle Navigator) in relation to the microcirculatory function, as asseesed with OPS and NIRS, in patients admitted for elective open cardiac surgery at the adult ICU.
- Main changes (audit trail)
- RECORD29-apr-2009 - 22-apr-2010


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