Steroids In caRdiac Surgery Trial - ND
- Conditions
- Require CPB for any cardiac surgical procedureMedDRA version: 13.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders
- Registration Number
- EUCTR2010-023093-39-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 7500
Age = 18 years 2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures) 3. EuroScore greater than or equal to 6 4. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period (e.g. cardiac transplantation) 2. History of bacterial or fungal infection in the last 30 days 3. Allergy or intolerance to corticosteroids 4. Receiving Aprotinin 5. Previous participation in this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method