Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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
Eligibility criteria
Qualifiers
Adult, i.e., above 18 years of age
Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
Disqualifiers
Acute surgery (i.e. off hours surgery)
Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.
Known endocarditis at time of screening
Previous participation in the trial
Trial design
Treatments tested in this trial
- Dexamethasone phosphate
- Isotonic sodium chloride (0.9%)
- Olanzapine 10 MG
- Placebo capsule
- Flow-targeted hemodynamic management
- Pressure-targeted hemodynamic management
- Low tidal-volume ventilation
- No ventilation
Treatment groups
1,200 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov