Vasoplegia, Cardiac Surgery
Conditions
Keywords
vasoplegia, cardiac surgery, steroids
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.
Interventions
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
DRUGSaline
Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
Sponsors
Instituto do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressors-free days | 30 days | Days free of vasopressors up to day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | 30 days | Duration in hours from the intraoperative intubation to postoperative extubation |
| 180 days mortallity | 180 days | The number of deaths within 180 days of surgery |
| Post-operative length of stay | 30 days | Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital. |
| Mesenteric ischemia | 30 days | We will compare the atrial fibrillation between groups within 30 days after randomization |
| Acute respiratory distress syndrome | 30 days | We will compare the incidence of acute respiratory distress syndrome between groups within 30 days after randomization |
| Stroke | 30 days | We will compare the incidence of stroke between groups within 30 days after randomization |
| Hyperglycemia | Up to 72 hours | Peak of capillary blood glucose glycemia up to 72 hours after the start the protocol solution |
Countries
Brazil
Outcome results
None listed