RecruitingNot ApplicableNCT05635227

Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac 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

Sponsor

Rigshospitalet, Denmark

Enrollment

1,200 participants

Start Date

Nov 10, 2022

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease Aortic Valve Disease

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

Min Age: 18 Years

Inclusion Criteria2

Adult, i.e., above 18 years of age
Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.

Exclusion Criteria20

Acute surgery (i.e. off hours surgery)
Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.
Known endocarditis at time of screening
Previous participation in the trial
Active infection, including bacterial, viral, and/or fungal infection
Known hepatic cirrhosis
Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L
Known severe neutropenia with neutrocyte levels \< 2 x 109/L
On the waiting list for a heart transplant
Recipient of any major organ transplant
Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.
Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.
Known narrow-angle glaucoma
Known phenylketonuria
Type I diabetes
Known long QT syndrome
Known allergy for any of the included study drugs
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'.