NCT05635227Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry): Recruiting
Study type: Interventional
Enrollment: 1200 (estimated)
First submitted: 13 Nov 2022
Start date: 10 Nov 2022
Primary completion date: Dec 2027
Lead sponsor: Copenhagen University Hospital, Rigshospitalet
Diseases: Coronary artery disease
NCT number: NCT05635227

What you commit to

Study type: Interventional
Planned participants: 1200
From 10 Nov 2022 to the primary completion date, Dec 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Acute surgery (i.e. off hours surgery)
Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.
Previous participation in the trial
Recipient of any major organ transplant
Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.

Other illness

Active infection, including bacterial, viral, and/or fungal infection
On the waiting list for a heart transplant
Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.
Type I diabetes
Known allergy for any of the included study drugs
Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study
- Patients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'.

Lab values

Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L
Known severe neutropenia with neutrocyte levels \< 2 x 109/L
Known long QT syndrome

Other

Known endocarditis at time of screening
Known hepatic cirrhosis
Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
Known narrow-angle glaucoma
Known phenylketonuria

Who the study is looking for

Adult, i.e., above 18 years of age
Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The Heart Centre, Rigshospitalet Coordinator of this site? Confirm its status	Copenhagen	Denmark	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.