drugset / Trial / NCT04301479

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

NCT04301479

Phase 3 Unknown 140 enrolled Instituto do Coracao
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-03
Primary completion
2021-03
Completion
2021-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocortisone Other / unclassified 200 mg

Indications