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 (GLORIOUS-II)

NCT05635227 NA RECRUITING

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

Details

Lead sponsor	Rigshospitalet, Denmark
Phase	NA
Status	RECRUITING
Enrolment	1200
Start date	2022-11-10
Completion	2028-02

Conditions

• Coronary Artery Disease
• Aortic Valve Disease

Interventions

• Dexamethasone phosphate
• Isotonic sodium chloride (0.9%)
• Olanzapine 10 MG
• Placebo capsule
• Flow-targeted hemodynamic management
• Pressure-targeted hemodynamic management
• Low tidal-volume ventilation
• No ventilation

Primary outcomes

• Days alive and outside hospital — 90 days from surgery

Countries

Denmark