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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Vasoplegia
• Intervention / Treatment: Drug: hydrocortisone sodium succinate; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Incor - Heart Institute - University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Placebo Comparator: 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.	Drug: Saline; Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasopressors-free days	Days free of vasopressors up to day 30	30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Duration in hours from the intraoperative intubation to postoperative extubation	30 days
Post-operative length of stay	Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.	30 days
Mesenteric ischemia	We will compare the atrial fibrillation between groups within 30 days after randomization	30 days
Acute respiratory distress syndrome	We will compare the incidence of acute respiratory distress syndrome between groups within 30 days after randomization	30 days
Stroke	We will compare the incidence of stroke between groups within 30 days after randomization	30 days
Hyperglycemia	Peak of capillary blood glucose glycemia up to 72 hours after the start the protocol solution	Up to 72 hours
180 days mortallity	The number of deaths within 180 days of surgery	180 days

Collaborators and Investigators

• Sponsor: Instituto do Coracao

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; vasoplegia; steroids
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Vasoplegia; Anti-Inflammatory Agents; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
• Other Study ID Numbers: InCor - HCFMUSP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No