drugset / Trial / NCT05635227

Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

NCT05635227

Recruiting 1200 enrolled Rigshospitalet, Denmark
RandomizedFactorialTriple-blindTreatment

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

Timeline

Start
2022-11-10
Primary completion
2027-12
Completion
2028-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 16.67 mg Intravenous
Subject Olanzapine Small molecule 10 mg Oral