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Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Sponsor: Rigshospitalet, Denmark
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
Official title: Dexamethasone, Olanzapine, Flow-targeted Versus Pressure-targeted Hemodynamic Management, and Low Tidal Volume Ventilation in Patients Undergoing On-pump Cardiac Surgery - a Multifactorial Design Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2022-11-10
Completion Date
2028-02
Last Updated
2025-04-04
Healthy Volunteers
No
Interventions
Dexamethasone phosphate
See description of arms
Isotonic sodium chloride (0.9%)
See description of arms
Olanzapine 10 MG
Olanzapine tablet pre-hidden in capsule identical to the placebo tablet
Placebo capsule
capsule identical to capsule containing olanzapine
Flow-targeted hemodynamic management
See description of arms
Pressure-targeted hemodynamic management
See description of arms
Low tidal-volume ventilation
See description of arms
No ventilation
See description of arms
Locations (1)
The Heart Centre, Rigshospitalet
Copenhagen, Denmark