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Recruiting NCT05635227

Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

Trial Parameters

Condition Coronary Artery Disease
Sponsor Rigshospitalet, Denmark
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-11-10
Completion 2027-12
Interventions
Dexamethasone phosphateIsotonic sodium chloride (0.9%)Olanzapine 10 MG

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. Adult, i.e., above 18 years of age 2. Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery. Exclusion Criteria: 1. Acute surgery (i.e. off hours surgery) 2. Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization. 3. Known endocarditis at time of screening 4. Previous participation in the trial 5. Active infection, including bacterial, viral, and/or fungal infection 6. Known hepatic cirrhosis 7. Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L 8. Known severe neutropenia with neutrocyte levels \< 2 x 109/L 9. On the waiting list for a heart transplant 10. Recipient of any major organ transplant 11. Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism 12. Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last

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