NCT05635227 Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
| NCT ID | NCT05635227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2022-11-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 6 months. 13. Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer. 14. Known narrow-angle glaucoma 15. Known phenylketonuria 16. Type I diabetes 17. Known long QT syndrome 18. Known allergy for any of the included study drugs 19. 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'.
Contact & Investigator
Christian Hassager, MD, DMSc
STUDY CHAIR
Sponsor GmbH
Frequently Asked Questions
Who can join the NCT05635227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05635227 currently recruiting?
Yes, NCT05635227 is actively recruiting participants. Contact the research team at sebastian.christoph.wiberg@regionh.dk for enrollment information.
Where is the NCT05635227 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05635227 clinical trial?
NCT05635227 is sponsored by Rigshospitalet, Denmark. The principal investigator is Christian Hassager, MD, DMSc at Sponsor GmbH. The trial plans to enroll 1,200 participants.