Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.
Am Heart J
; 220: 192-202, 2020 02.
Article
in En
| MEDLINE
| ID: mdl-31855716
ABSTRACT
For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age <â¯1â¯year) undergoing heart surgery with CPB. Participants (planned enrollmentâ¯=â¯1,200) are randomized 11 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic "trial within a registry" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Postoperative Complications
/
Methylprednisolone
/
Cardiopulmonary Bypass
/
Systemic Inflammatory Response Syndrome
/
Heart Defects, Congenital
/
Anti-Inflammatory Agents
Type of study:
Clinical_trials
/
Risk_factors_studies
Limits:
Humans
/
Infant
/
Newborn
Country/Region as subject:
America do norte
Language:
En
Journal:
Am Heart J
Year:
2020
Document type:
Article
Affiliation country:
New Caledonia