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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vasoplegia, Cardiac Surgery

Intervention / Treatment
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* Drug: hydrocortisone sodium succinate
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid<br>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<br>* 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<br>|
| Placebo Comparator: Control<br>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<br>* Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasoplegia, cardiac surgery, steroids