Investigating Dexamethasone and Olanzapine in Heart Surgery
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
This study is testing different treatments and strategies during heart surgery to see if they can help patients recover faster and spend more days at home after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05635227 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of four different interventions on patients undergoing open heart surgery, specifically coronary artery bypass grafting (CABG) and aortic valve replacement (AVR). The interventions include administering dexamethasone or a placebo after anesthesia induction, olanzapine or a placebo before anesthesia, a blood-flow targeted versus a blood-pressure targeted hemodynamic strategy during cardiopulmonary bypass, and low-tidal volume ventilation versus no ventilation during the procedure. The primary endpoint is the number of days alive and outside the hospital within 90 days post-surgery. The study aims to reduce the risk of mortality and morbidity associated with these surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults scheduled for elective CABG and/or AVR.
Not a fit: Patients requiring acute surgery, those with active infections, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes and reduced hospital stays for patients undergoing heart surgery.
How similar studies have performed: Other studies have explored similar interventions in cardiac surgery, but this specific combination of treatments is novel.
Eligibility criteria
Show full inclusion / exclusion 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'.
Where this trial is running
Copenhagen
- The Heart Centre, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Sebastian Wiberg, MD, PhD
- Email: sebastian.christoph.wiberg@regionh.dk
- Phone: +45 35 45 17 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.