Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05635227
NA

Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2022-11-10

Completion Date

2028-02

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone phosphate

See description of arms

DRUG

Isotonic sodium chloride (0.9%)

See description of arms

DRUG

Olanzapine 10 MG

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

DRUG

Placebo capsule

capsule identical to capsule containing olanzapine

PROCEDURE

Flow-targeted hemodynamic management

See description of arms

PROCEDURE

Pressure-targeted hemodynamic management

See description of arms

PROCEDURE

Low tidal-volume ventilation

See description of arms

PROCEDURE

No ventilation

See description of arms

Locations (1)

The Heart Centre, Rigshospitalet

Copenhagen, Denmark