Actively Recruiting
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
Led by Rigshospitalet, Denmark · Updated on 2025-04-04
1200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of four different interventions in adults undergoing open heart surgery, including coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR). The goal is to study how these interventions impact the number of days patients are alive and out of the hospital within 90 days after surgery. This randomized clinical trial addresses risks of mortality and organ injury associated with cardiac surgery and cardiopulmonary bypass (CPB). The study evaluates important factors like inflammation, organ perfusion, and lung protection during surgery.
CONDITIONS
Brief 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 concomitant valve surgery
You will not qualify if you...
- Acute surgery (off hours surgery)
- Pregnancy or currently breastfeeding
- Known endocarditis at time of screening
- Previous participation in the trial
- Active bacterial, viral, or fungal infection
- Known hepatic cirrhosis
- Severe thrombocytopenia with platelet levels below 50 x 10^9/L
- Severe neutropenia with neutrophil levels below 2 x 10^9/L
- On the waiting list for a heart transplant
- Recipient of any major organ transplant
- Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
- Received chemotherapy or radiation therapy for malignancy within the 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 drugs
- Any condition that could increase risk, confound results, or interfere with participation
- Patients with extracardiac arteriopathy will be excluded from the hemodynamic management interventions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive study interventions including dexamethasone or placebo intravenously after anesthesia induction, oral olanzapine or placebo before surgery, hemodynamic management targeting either flow or pressure during cardiopulmonary bypass, and low tidal-volume ventilation or no ventilation during cardiopulmonary bypass.
1 surgical visit (in-person)
Duration - Up to 180 days after surgery
Participants are followed to assess outcomes including days alive outside hospital, organ function, complications, delirium, quality of recovery, survival, and quality of life up to 180 days after surgery.
Multiple follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
The Heart Centre, Rigshospitalet
Copenhagen, Denmark, 2200
Actively Recruiting
Research Team
S
Sebastian Wiberg, MD, PhD
C
Christian Hassager, MD, DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here