The most severely ill patients have the poorest peripheral tissue perfusion and oxygenation, which will negatively influence the accuracy of continuous glucose monitoring measurements.
ID
Bron
Verkorte titel
Aandoening
continuous glucose monitoring (continue glucose monitoring)
microcirculation (microcirculatie)
intensive care unit (intensive care)
cardiothoracic surgery (cardiothoracale chirurgie)
Ondersteuning
Onze Lieve Vrouwen Gasthuis
Oosterpark 9, 1091 AC Amsterdam, the Netherlands
Email: p.h.j.vandervoort@olvg.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference 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.
Achtergrond van het onderzoek
Study 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.
Doel van het onderzoek
The most severely ill patients have the poorest peripheral tissue perfusion and oxygenation, which will negatively influence the accuracy of continuous glucose monitoring measurements.
Onderzoeksopzet
1. 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.
Onderzoeksproduct en/of interventie
N/A
Publiek
Academic Medical Center,
Department of Internal Medicine, room F4-255
Meibergdreef 9,
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665981
s.e.siegelaar@amc.uva.nl
Wetenschappelijk
Academic Medical Center,
Department of Internal Medicine, room F4-255
Meibergdreef 9,
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5665981
s.e.siegelaar@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Abdominal abnormalities that inhibit sensor insertion.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1689 |
NTR-old | NTR1790 |
Ander register | VCMO Nieuwegein : R-08.35O |
ISRCTN | ISRCTN wordt niet meer aangevraagd |