BridgeMD
Dexamethasone, olanzapine, hemodynamics, and ventilation in cardiac surgery (GLORIOUSII)
EU CTIS ID: 2024-515998-94-00
What this study is testing
The primary objective of this trial is to determine the efficacy of dexamethasone compared with placebo on the primary endpoint days alive outside hospital within 90 days in adult subjects undergoing elective or subacute isolated CABG, isolated AVR, or CABG plus any concomitant valve surgery. The coprimary objectives are to determine the efficacy of olanzapine versus placebo administered preoperatively, the efficacy of flow-targeted versus pressure-targeted hemodynamic management during CPB, and the efficacy of low tidal volume ventilation versus no ventilation during CPB, on the endpoint days alive outside hospital within 90 days in adult subjects undergoing elective or subacute isolated CABG, isolated AVR, or CABG plus any concomitant valve surgery.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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)
- 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
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)
- 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
- 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
- Recipient of any major organ transplant
- Patients with extracardiac arteriopathy (assessed as part of the preoperative EuroSCORE) will be excluded from the intervention 'flowtargeted vs. pressure-targeted hemodynamic management during CPB'.
- 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
- Pregnancy or currently breastfeeding
- Known endocarditis at time of screening
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.