Investigating Dexamethasone and Olanzapine in Heart Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.