1. Cardiac surgery (Hartchirurgie)
Conditions
Interventions
Administration of dexamethasone 1 mg/kg, or placebo.
Sponsors
UMC Utrecht, Division of Perioperative Care & Emergency Medicine (Prof.dr. C.J. Kalkman)
Eligibility
Inclusion criteria
Inclusion criteria: All types of cardiac surgery in which cardiopulmonary bypass is used.
Exclusion criteria
Exclusion criteria: 1. Age under 18 years; 2. Life-expectancy <6 months; 3. Emergency operations; 4. Re-operations within the same admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. The occurrence of one or more major complications within the first year after surgery; 2. the separate components of the primary outcome measure, i.e. major complications in the first 30 days after surgery; 3. quality of life at 30 days and one year after surgery; 4. wound infection in the first 30 days after surgery; 5. use of anti-anginal drugs at 30 days after surgery; 6. atrial fibrillation in ICU; 7. highest serum glucose concentration in ICU; 8. use of inotropes on the first postoperative day; 9. highest body temperature in ICU; 10. time to extubation; 11. time to discharge from ICU; 12. time to discharge from hospital; 13. change in cognitive performance from before to 30 days after surgery (subsample of 400 patients); 14. serum glucose-values and insulin use in ICU (subsample of patients in the UMC Utrecht); 15. cost-effectiveness analysis. | — |
Contacts
Public ContactJ.M Dieleman
PO Box 85500,
Outcome results
None listed