Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Key facts
- Where
- Copenhagen, DenmarkSee the site
Where in Denmark
- The Heart Centre, RigshospitaletCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT05635227
- Record updated
- 4 April 2025
- Original description
Open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) is associated with a significant risk of mortality.Read full original descriptionShow less
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
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
Inclusion: Adult, i.e., above 18 years of age; Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
Exclusion: 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; Previous participation in the trial; Recipient of any major organ transplant; Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months; Active infection, including bacterial, viral, and/or fungal infection; On the waiting list for a heart transplant; Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer; Type I diabetes; Known allergy for any of the included study drugs; Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study; Patients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'; Known severe thrombocytopenia with thrombocyte levels < 50 x 109/L; Known severe neutropenia with neutrocyte levels < 2 x 109/L; Known long QT syndrome; Known endocarditis at time of screening; Known hepatic cirrhosis; Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism; Known narrow-angle glaucoma; Known phenylketonuria.