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

Plain Language Summary

Simplified for easier understanding

This study tests whether giving dexamethasone (a steroid) and olanzapine (typically used for nausea/vomiting) to patients having heart bypass surgery (CABG) or aortic valve replacement (AVR) improves recovery, reduces inflammation, and lowers the need for a breathing machine afterward. **You may be eligible if...** - You are 18 years or older - You are scheduled for planned (non-emergency) bypass surgery and/or aortic valve replacement **You may NOT be eligible if...** - Your surgery is urgent or emergency surgery - You are pregnant or breastfeeding - You have a known heart infection (endocarditis) - You have participated in a similar study before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone phosphate

See description of arms

DRUGIsotonic sodium chloride (0.9%)

See description of arms

DRUGOlanzapine 10 MG

Olanzapine tablet pre-hidden in capsule identical to the placebo tablet

DRUGPlacebo capsule

capsule identical to capsule containing olanzapine

PROCEDUREFlow-targeted hemodynamic management

See description of arms

PROCEDUREPressure-targeted hemodynamic management

See description of arms

PROCEDURELow tidal-volume ventilation

See description of arms

PROCEDURENo ventilation

See description of arms

Locations(1)

The Heart Centre, Rigshospitalet

Copenhagen, Denmark

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NCT05635227

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