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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Active Comparator | 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. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone sodium succinate | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressors-free days | Days free of vasopressors up to day 30 | 30 days |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Saline | Drug | Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal |
|
| 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 |
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |