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Tissue oxygenation and perfusion and the determination of glucose subcutaneously

Completed
Conditions
glucose metabolism
10018424
10007593
Registration Number
NL-OMON34018
Lead Sponsor
Onze Lieve Vrouwe Gasthuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

Willing and able to give written informed consent
admittance to the OLVG for elective open cardiac surgery (coronary artery bypass graft [CABG]; mitral-, tricuspidal- and aortic valve surgery)
age 18-85 years

Exclusion Criteria

abdominal abnormalities that inhibit sensor insertion

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Difference in glucose values (mmol/l) measured by the two CGMs, Guardian RT and<br /><br>FreeStyle Navigator compared to *gold standard* blood glucose values measured<br /><br>by the Accu-Chek Compact plus (mmol/l), expressed as mean absolute difference<br /><br>(MAD) of glucose values. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. Microcirculatory function expressed as % of perfused vessels as measured by<br /><br>OPS.<br /><br>2. Microcirculatory function expressed as microvascular flow index (MFI) as<br /><br>measured by OPS.<br /><br>3. Tissue oxygen saturation (StO2) expressed as ratio oxygenated haemoglobin to<br /><br>total haemoglobin as measured by near infrared spectroscopy (NIRS).<br /><br>4. Systemic oxygen saturation (SpO2) expressed as % as measured by pulse<br /><br>oximetry.<br /><br>5. APACHE II score.<br /><br>6. SOFA score.<br /><br>7. Glucose values expressed as mmol/l as measured by the Accu-Chek Compact<br /><br>plus. </p><br>
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