Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery

NCT05635227 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2022-11-10
Last updated
2025-04-04

Condition(s) studied

Coronary Artery DiseaseAortic Valve Disease

Investigational drug(s) / intervention(s)

Dexamethasone phosphate →Isotonic sodium chloride (0.9%) →Olanzapine 10 MG →Placebo capsuleFlow-targeted hemodynamic managementPressure-targeted hemodynamic managementLow tidal-volume ventilationNo ventilation

Dexamethasone phosphate: See description of arms

Isotonic sodium chloride (0.9%): See description of arms

Olanzapine 10 MG: Olanzapine tablet pre-hidden in capsule identical to the placebo tablet

Placebo capsule: capsule identical to capsule containing olanzapine

Flow-targeted hemodynamic management: See description of arms

Pressure-targeted hemodynamic management: See description of arms

Low tidal-volume ventilation: See description of arms

No ventilation: See description of arms

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult, i.e., above 18 years of age 2. Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery. Exclusion Criteria: 1. Acute surgery (i.e. off hours surgery) 2. Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization. 3. Known endocarditis at time of screening 4. Previous participation in the trial 5. Active infection, including bacterial, viral, and/or fungal infection 6. Known hepatic cirrhosis 7. Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L 8. Known severe neutropenia with neutrocyte levels \< 2 x 109/L 9. On the waiting list for a heart transplant 10. Recipient of any major organ transplant 11. Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism 12. Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months. 13. Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer. 14. Known narrow-angle glaucoma 15. Known phenylketonuria 16. Type I diabetes 17. Known long QT syndrome 18. Known allergy for any of the included study drugs 19. 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'.

Primary outcome measure(s)

  • Days alive and outside hospital — 90 days from surgery

Trial sites (1)

FacilityCityRegionStatus
The Heart Centre, Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05635227 on ClinicalTrials.gov ↗ ← All trials in Denmark