Peri-operative Accuracy and Safety of Real Time Continuous Glucose Monitoring System in cardiac surgical patients. A pilot study
Recruiting
- Conditions
- Hyperglycaemiablood glucose regulation10018424
- Registration Number
- NL-OMON29812
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
scheduled for elective cardiac surgery
age over 18
expected stay in hospital > 3 days
Exclusion Criteria
failure to obtain informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Correlation between data obtained with the RT-CGMS and the conventional method.<br /><br>Pairs of data will be analysed using correlation coefficients and Continuous<br /><br>Glucose Error Grid Analysis.<br /><br><br /><br>Adverse effects of the RT-CGMS : irritation of skin, disconnection etc.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Degree of glucose control defined as the percent and time of blood glucose<br /><br>measurements in normoglycaemia, hypoglycaemia and hyperglycaemia, as recorded<br /><br>both with sensor measurements and ward measurements; insulin dose; frequency of<br /><br>insulin dose adjustments; time to reach normoglycaemia.<br /><br><br /><br>Occurrence of clinical events; hypothermia (Temperature < 36 degrees Celsius),<br /><br>shock (systolic blood pressure<100 mm Hg), acidosis (pH <7.35), other events<br /><br>deemed significant in glucose metabolism and its effect on RT-CGMS.<br /><br><br /><br>Other study parameters: sex, age, body weight, body height, BMI, history of<br /><br>diabetes mellitus, presence of risk factors for diabetes mellitus, Severity<br /><br>score, reasons for ICU admission, use of relevant clinical intervention<br /><br>(nutrition therapy, corticosteroid, vasopressors, etc)</p><br>