drugset / Trial / NCT05635227
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
RandomizedFactorialTriple-blindTreatment
Summary
Open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) is associated with a significant risk of mortality. This study is a randomized clinical trial with the purpose of investigating four different interventions on the primary endpoint 'days alive and outside of hospital within 90 days'. The interventions are: * Dexamethasone vs. placebo administered after induction of anesthesia. * Olanzapine vs. placebo administered prior to anesthesia. * A blood-flow targeted vs. a blod-pressure targeted hemodynamic strategy while the patient is on cardio-pulmonary bypass (CPB) * Low-tidal volume ventilation vs. no ventilation of the lungs while the patient is on CPB
Timeline
- Start
- 2022-11-10
- Primary completion
- 2027-12
- Completion
- 2028-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 16.67 mg | Intravenous |
| Subject | Olanzapine | Small molecule | 10 mg | Oral |