Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Condition: Heart Disease Congenital Complex
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      This protocol is designed to offer insight into critical illness related corticosteroid
      insufficiency and steroid supplementation in neonates undergoing cardiac surgery with
      cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative
      period.
    

Detailed description: 
      Open-heart surgery with cardiopulmonary bypass (CPB) induces an acute systemic inflammatory
      response (SIRS) via synthesis and release of inflammatory mediators. These inflammatory
      cascades may result in the development of capillary leak and generalized tissue edema, which
      are associated with multiorgan dysfunction involving the myocardium, lungs, kidneys,
      pancreas, and central nervous system. Neonates are especially susceptible to the injurious
      effects of SIRS. In attempt to blunt post-bypass SIRS, most neonatal heart programs have
      protocols in which patients receive preoperative and/or intraoperative steroids. Despite this
      widespread use, studies have not demonstrated consistent benefit in this therapy, and
      neonates often continue to suffer the deleterious effects of SIRS postoperatively. Only one
      study was designed to evaluate the impact of prophylactic postoperative steroid
      administration on outcomes after neonatal CPB. The early postoperative periods is a crucial
      time during which attenuation of CPB-induced SIRS by exogenous steroids may lead to improved
      clinical outcomes.

      Adrenal insufficiency in neonates post-CPB may accentuate the harmful effects of SIRS by
      diminishing the anti-inflammatory and hemodynamic stabilization benefits of endogenous
      cortisol. Evidence suggests that neonates may suffer from inadequate cortisol activity
      relative to the severity of illness post-CPB, in part related to immaturity of their
      hypothalamic-pituitary-adrenal (HPA) axis. This so-called critical illness-related
      corticosteroids insufficiency (CIRCI) may contribute to low cardiac output syndrome (LCOS),
      respiratory dysfunction, and capillary leak in the postoperative period.

      Much of the support for CIRCI as a contributor to LCOS after CPB originates from small
      clinical studies that demonstrate benefit of exogenous steroid supplementation on various
      short term clinical outcomes in patients with shock. Yet it is not clear if benefit from
      exogenous steroids suggests by dysregulation of the HPA axis or whether these are merely
      alternative effects of steroids. Investigators have recently begun to describe the cortisol
      response in neonates post-CPB, but there is no consensus regarding the incidence of
      clinically important adrenal insufficiency, its identification, or who should receive
      exogenous steroids.
    

Intervention name(s): Hydrocortisone; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.; This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.
Other intervention name(s): Solu Cortef; 0.9% Sodium Chloride
Intervention MeSH terms: Hydrocortisone; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment