Dexamethasone for Cardiac Surgery study
Recruiting
- Conditions
- 1. Cardiac surgery (Hartchirurgie)<br />2. Systemic Inflammatory Response Syndrome (SIRS).
- Registration Number
- NL-OMON19963
- Lead Sponsor
- MC Utrecht, Division of Perioperative Care & Emergency Medicine (Prof.dr. C.J. Kalkman)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4500
Inclusion Criteria
All types of cardiac surgery in which cardiopulmonary bypass is used.
Exclusion Criteria
1. Age under 18 years;
2. Life-expectancy <6 months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.
- Secondary Outcome Measures
Name Time Method 1. The occurrence of one or more major complications within the first year after surgery;<br /><br>2. the separate components of the primary outcome measure, i.e. major complications in the first 30 days after surgery;<br /><br>3. quality of life at 30 days and one year after surgery;<br /><br>4. wound infection in the first 30 days after surgery;<br /><br>5. use of anti-anginal drugs at 30 days after surgery;<br /><br>6. atrial fibrillation in ICU;<br /><br>7. highest serum glucose concentration in ICU;<br /><br>8. use of inotropes on the first postoperative day;<br /><br>9. highest body temperature in ICU;<br /><br>10. time to extubation;<br /><br>11. time to discharge from ICU;<br /><br>12. time to discharge from hospital;<br /><br>13. change in cognitive performance from before to 30 days after surgery (subsample of 400 patients);<br /><br>14. serum glucose-values and insulin use in ICU (subsample of patients in the UMC<br>Utrecht);<br /><br>15. cost-effectiveness analysis.