NCT04301479

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

Low Dose Corticosteroid Infusion in Vasoplegia After Cardiac Surgery (CORTIVAS-CS): a Prospective Randomized Double-blinded Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Instituto do Coracao · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasoplegia
• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	hydrocortisone sodium succinate	Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
DRUG	Saline	Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-03-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: Brazil