Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

Launched by RIGSHOSPITALET, DENMARK · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring ways to improve recovery after open heart surgery, specifically for patients undergoing coronary artery bypass grafting (CABG) or aortic valve replacement (AVR). The study is looking at four different treatments to see which one helps patients spend more days at home and out of the hospital within 90 days after surgery. The treatments include a steroid called dexamethasone, an antipsychotic medication called olanzapine, different methods of managing blood flow during surgery, and varying types of breathing support while the patient's heart is temporarily stopped.

To be eligible for this trial, participants must be adults over 18 years old who are scheduled for CABG and/or AVR. However, individuals with certain health conditions, such as active infections, pregnancy, or severe blood disorders, will not be able to participate. If you join the trial, you will be randomly assigned to one of the treatment groups and monitored closely to see how well you recover after your surgery. This study aims to find better ways to help patients recover after heart surgeries and improve their quality of life.

Gender

ALL

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'.