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

Phase 3

• Conditions: Vasoplegia; Cardiac Surgery
• Interventions: Drug: Saline; Drug: hydrocortisone sodium succinate

• Registration Number: NCT04301479
• Lead Sponsor: Instituto do Coracao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Status Verified: 2020-03
• Study Start: 2020-03
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	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.
Steroid	hydrocortisone sodium succinate	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.

Primary Outcome Measures

Name	Time	Method
Vasopressors-free days	30 days	Days free of vasopressors up to day 30

Secondary Outcome Measures

Name	Time	Method
30 days mortallity	30 days	The number of deaths within 30 days of surgery
ICU length of stay	30 days	Duration in days from the date of the ICU admission to the date of ICU discharge
Infection complication	30 days	Rate of new infection or septic shock within 30 days after randomization
Acute myocardial infarction	30 days	We will compare the incidence of acute myocardial infarction between groups within 30 days after randomization
Atrial fibrillation	30 days	We will compare the incidence of atrial fibrillation between groups within 30 days after randomization

Trial Locations

Locations (1)

Incor - Heart Institute - University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil