Tocilizumab, Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

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 five different interventions on the primary endpoint 'days alive and outside of hospital within 90 days'.

The interventions are:

• Tocilizumab vs. placebo administered after induction of anesthesia.

• 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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Dexamethasone; Dexamethasone 21-phosphate; Olanzapine

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. Having received tocilizumab within the past 6 months

20. 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