DEXAMETHASONE DISODIUM PHOSPHATE for Ischaemic heart disease | Valvular heart disease

Inclusion criteria

• {"criterion_text":"-Adult, i.e., above 18 years of age\n-Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery."}

Exclusion criteria

• {"criterion_text":"-Acute surgery (i.e. off hours surgery)\n-Recipient of any major organ transplant\n-Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism\n-Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months\n-Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.\n-Known narrow-angle glaucoma\n-Known phenylketonuria\n-Pregnancy or currently breastfeeding\n-Known endocarditis at time of screening\n-Previous participation in the trial\n-Active infection, including bacterial, viral, and/or fungal infection\n-Known hepatic cirrhosis\n-Known severe thrombocytopenia with thrombocyte levels < 50 x 109/L\n-Known severe neutropenia with neutrocyte levels < 2 x 109/L\n-On the waiting list for a heart transplant\n-Type I diabetes\n-Known long QT syndrome\n-Known allergy for any of the included study drugs\n-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\n-Patients with extracardiac arteriopathy (assessed as part of the preoperative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'."}

Primary endpoints

• {"endpoint_text":"-The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.","definition_or_measurement_approach":"Number of days alive and outside hospital within 90 days after surgery (days alive outside hospital within 90 days)."}

Secondary endpoints

• {"endpoint_text":"-Time in days to occurrence of any component in a composite secondary endpoint during follow-up: a) Death from any cause, b) Stroke, c) Acute kidney injury or d) New onset or worsening heart failure\n-Severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5.\n-Delirium during the first 7 days after surgery, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) score or a positive Confusion Assessment Method (CAM) score for the general wards\n-Quality of Recovery-15 (QoR-15) score 3 days, or as soon as possible, after surgery\n-90-day outcomes: Survival, Change in modified Rankin Scale (mRS) from baseline, Health-related quality of life (EQ-5D-5L), Change in self-perceived function \"two simple questions\" and Days alive outside ICU\n-180-day outcomes: Survival","definition_or_measurement_approach":"Composite endpoint: time in days to first occurrence of death, stroke, acute kidney injury, or new/worsening heart failure. Severe complications defined as Clavien-Dindo class 3-5. Delirium defined by CAM-ICU or CAM. QoR-15 measured at day 3 (or as soon as possible). 90-day outcomes include survival, mRS change, EQ-5D-5L, self-perceived function, and days alive outside ICU. 180-day outcome is survival."}

Denmark

Earliest CTIS Part Ii Submission Date

11-10-2024

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

504

Number Of Sites

3

Number Of Participants

1200

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"1","organisation_type":"Educational Institution"}