Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
Dexamethasone phosphate: See description of arms
Isotonic sodium chloride (0.9%): See description of arms
Olanzapine 10 MG: Olanzapine tablet pre-hidden in capsule identical to the placebo tablet
Placebo capsule: capsule identical to capsule containing olanzapine
Flow-targeted hemodynamic management: See description of arms
Pressure-targeted hemodynamic management: See description of arms
Low tidal-volume ventilation: See description of arms
No ventilation: See description of arms
Study 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
Primary outcome measure(s)
- Days alive and outside hospital — 90 days from surgery
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Heart Centre, Rigshospitalet | Copenhagen | Denmark | Recruiting |
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05635227 on ClinicalTrials.gov ↗ ← All trials in Denmark