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

Instituto do Coracao

Status and phase: Unknown; Phase 3

Conditions: Cardiac Surgery; Vasoplegia

Treatments: Drug: Saline; Drug: hydrocortisone sodium succinate

Study type: Interventional

Funder types: Other

Identifiers

NCT04301479

InCor - HCFMUSP

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

140 participants in 2 patient groups, including a placebo group

Steroid

Active Comparator group

Description:

Patients assigned for 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, defined by systolic arterial pressure \> 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.

Treatment:

Drug: hydrocortisone sodium succinate

Control

Placebo Comparator group

Description:

Patients assigned for control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal, defined by systolic arterial pressure \> 90 mmHg for 12 hours after vasopressor weaning without fluid expansion.

Treatment:

Drug: Saline