Status:
UNKNOWN
Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)
Lead Sponsor:
Instituto do Coracao
Conditions:
Vasoplegia
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Vasoplegia is an important determinant for adverse postoperative outcome and is observerd in 5% to 54% of patients undergoing cardiac surgery using cardiopulmonary bypass (CPB). Postoperative vasople...
Eligibility Criteria
Inclusion
- Cardiac surgery with cardiopulmonary bypass
- Norephinerine treatment in ICU with dose great or equal than 0,1 mcg/kg/min to maintain or restore a MAP over 70 mmHg for at least 30 minutes within 24 hours after surgery
Exclusion
- Preoperative vasopressor use (within 72 hours prior to surgery)
- Preoperative steroids use (within 7 days prior to surgery)
- Presence of ventricular assist device other than intraaortic ballon pump
- Transplant procedures
- Emergency procedures
- Aortic repairs
- Congenital procedures
- Endocarditis
- Bacterial or fungal infection in the preceding 30 days
- Active neoplasia
- Pregnancy
- Recent history of gastrointestinal bleeding
- Allergy or intolerance to steroids
- Participation in other study
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04301479
Start Date
March 1 2020
End Date
March 1 2021
Last Update
March 10 2020
Active Locations (1)
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1
Incor - Heart Institute - University of Sao Paulo
São Paulo, Brazil, 05403000