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

NCT ID: NCT04301479

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-03-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Steroid

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.

Group Type: ACTIVE_COMPARATOR

hydrocortisone sodium succinate

Intervention Type: DRUG

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

Control

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

Interventions

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

Intervention Type: DRUG

Saline

Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coracao

OTHER_GOV

Sponsor Role: lead

Responsible Party

Filomena R B G Galas

Associate Professor of Anesthesiology at University São Paulo Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Incor - Heart Institute - University of Sao Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

InCor - HCFMUSP

Identifier Type: -

Identifier Source: org_study_id