Actively Recruiting
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Led by Rigshospitalet, Denmark · Updated on 2025-04-04
1200
Participants Needed
1
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult, i.e., above 18 years of age
- Scheduled for coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR), including any other valve surgery
You will not qualify if you...
- Acute (off hours) surgery
- Pregnant or currently breastfeeding
- Known endocarditis at screening
- Previous participation in this trial
- Active bacterial, viral, or fungal infection
- Known liver cirrhosis
- Severe thrombocytopenia (platelets < 50 x 10^9/L)
- Severe neutropenia (neutrophils < 2 x 10^9/L)
- On waiting list for heart transplant
- Recipient of any major organ transplant
- Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
- Received chemotherapy or radiation for cancer within last 6 months
- Current malignancy except basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia, or stable prostate cancer
- Known narrow-angle glaucoma
- Known phenylketonuria
- Type I diabetes
- Known long QT syndrome
- Allergy to any study drug
- Any condition posing risk or interfering with study participation
- Patients with extracardiac arteriopathy are excluded from the hemodynamic management intervention
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Trial Site Locations
Total: 1 location
1
The Heart Centre, Rigshospitalet
Copenhagen, Denmark, 2200
Actively Recruiting
Research Team
S
Sebastian Wiberg, MD, PhD
CONTACT
C
Christian Hassager, MD, DMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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