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Prolonged corticosteroid therapy in scheduled cardiac surgery in intermediate/high-risk patients: a prospective multicenter randomized controlled double-blind placebo-controlled study
EU CTIS ID: 2024-517699-39-00
What this study is testing
demonstrate the efficacy of prolonged corticosteroid therapy for 5 days (Hydrocortisone + Fludrocortisone) versus placebo in intermediate/high-risk patients undergoing scheduled cardiac 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
- Age > 18 years.
- Patient at intermediate/high risk (Euroscore II>4%)
- Patient admitted for scheduled cardiac surgery
- Extracorporeal circulation
- signed informed consent
You likely can't join if
- Endocarditis
- End-stage renal failure with long-term dialysis
- - Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the drugs' prescribing information
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or safeguard of justice
- Beating heart surgery
See the full eligibility criteria
- Age > 18 years.
- Patient at intermediate/high risk (Euroscore II>4%)
- Patient admitted for scheduled cardiac surgery
- Extracorporeal circulation
- signed informed consent
- Endocarditis
- End-stage renal failure with long-term dialysis
- - Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the drugs' prescribing information
- Pregnant or breast-feeding women
- Patients under guardianship, curatorship or safeguard of justice
- Beating heart surgery
- Heart transplantation or long-term ventricular assistance
- Emergency surgery: aortic dissection, emergency coronary artery bypass surgery
- Failed exit from bypass with need for short-acting assistance (counterpulsation balloon, ECMO)
- Hypothermic surgery
- Previous cardiac surgery
- Patient on long-term corticosteroid therapy
- Autoimmune or chronic inflammatory disease.
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. 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.