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New treatment option for Coronary Artery Disease
Official title Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery
ClinicalTrials.gov ID: NCT05635227
What this study is testing
What is Dexamethasone phosphate?
Dexamethasone phosphate is an investigational medicine, given as an once-daily, being studied as a potential treatment for coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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'.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult, i.e., above 18 years of age
- Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
You likely can't join if
- 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.
- Known endocarditis at time of screening
- Previous participation in the trial
- Active infection, including bacterial, viral, and/or fungal infection
- Known hepatic cirrhosis
See the full eligibility criteria
- Adult, i.e., above 18 years of age
- Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
- 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.
- Known endocarditis at time of screening
- Previous participation in the trial
- Active infection, including bacterial, viral, and/or fungal infection
- Known hepatic cirrhosis
- Known severe thrombocytopenia with thrombocyte levels \< 50 x 109/L
- Known severe neutropenia with neutrocyte levels \< 2 x 109/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
- Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.
- Clinical evidence of current malignancy except for 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.