Overview

Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS)

Status:
Not yet recruiting
Trial end date:
2021-03-01
Target enrollment:
0
Participant gender:
All
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 vasoplegia is defined as a state with low systemic vascular resistance despite a normal or high cardiac output, and the need for vasopressor therapy. Steroids attenuate the inflammatory response to cardiopulmonary bypass,but their effect on clinical outcomes is uncertain. This is a double-blinded, randomized, clinical trial designed to determine the efficacy of low dose corticosteroid infusion in vasopressor free-days in vasoplegia after cardiac surgery.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto do Coracao
Treatments:
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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