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Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

NCT05635227 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-04-04

No results posted yet for this 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

Conditions

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Christian Hassager, MD, DMSc · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2027-12-31
Completion
2028-02-29

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635227 on ClinicalTrials.gov