Clinical Trial: Impact of Pre-operative Steroids on Adrenal Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Impact of Pre-operative Steroids on Adrenal Insufficiency and Clinical Outcomes After Neonatal Cardiac Surgery With Cardiopulmonary Bypass

Brief Summary: Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI7. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room. Recent evidence has begun to highlight potential morbidity associated with perioperative steroid administration. Our cardiac surgery program is changing clinical practice and ceasing to give preoperative steroids to all patients (previously only neonatal CPB patients received preoperative methylprednisolone). With the possibility that preoperative steroid administration, and not CPB, primarily causes the high incidence of AI, it is prudent to further investigate the benefit and/or harm of perioperative steroid administration

Detailed Summary:

Cardiopulmonary bypass (CPB) induces systemic inflammatory response syndrome (SIRS), which may contribute to postoperative morbidity. Neonates experience an exaggerated inflammatory response and may be at a higher risk for the deleterious effects of CPB. SIRS may disrupt the hypothalamic-pituitary-adrenal (HPA) axis leading to a relative adrenal insufficiency (AI) after neonatal CPB. There is some emerging evidence supporting an association of AI with morbidity in neonates after cardiac surgery. Postoperative steroids may offer hemodynamic benefits to neonates suffering from low cardiac output syndrome (LCOS) following CPB. Benefit of postoperative steroids is multifactorial including: suppression of inflammatory cytokines, direct actions on the heart and vascular smooth muscle, and treatment of AI in a subset of patients.

Little is known regarding the incidence and clinical impact of AI in neonates during the acute postoperative period following separation from CPB. In a randomized control pilot study performed by the UAB CVICU research team, prophylactic post-CPB hydrocortisone infusions improved some postoperative outcomes, especially in those that acquired AI. In an attempt to further explore post-CPB AI, a retrospective analysis of data from this study was performed. Of the 40 neonates included in the study, one-third (32.5%) developed AI following CPB (as determined by low-dose, 1 µg, cosyntropin stimulation test). Almost all of these subjects had normal response to cosyntropin stimulation pre-CPB. Subjects that developed AI demonstrated more hemodynamic instability, increased serum lactate and required more colloid resuscitation in the immediate post-CPB period in the operating room.

In this retrospective analysis by Crawford et al.8 ACTH levels were found to be significantly lower post-CPB compared to preopera
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Incidence of AI in neonates who do not receive preoperative methylprednisolone [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Hemodynamic parameters-Heart rate [ Time Frame: 1.5 hours post-CPB ]
  hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure-heart rate
• Hemodynamic parameters- Blood pressure [ Time Frame: 1.5 hours post-CPB ]
  hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure systolic blood pressure
• Hemodynamic parameters- Central venous pressure [ Time Frame: 1.5 hours post-CPB ]
  hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure central venous pressure
• Hemodynamic parameters- Flank Near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]
  hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure flank near infrared spectroscopy.
• Hemodynamic parameters- cerebral near infrared spectroscopy [ Time Frame: 1.5 hours post-CPB ]
  hemodynamic parameters collected every 15 minutes post-CPB for 1.5 hours or until the end of the procedure cerebral near infrared spectroscopy.
• Laboratory values- lactacte [ Time Frame: 1 week post-CPB ]
  serum lactate
• Laboratory values- Hematocrit [ Time Frame: 1 week post-CPB ]
  hematocrit
• Laboratory values- hemoglobin [ Time Frame: 1 week post-CPB ]
  hemoglobin
• Laboratory values- Mixed venous [ Time Frame: 1 week post-CPB ]
  mixed venous oxygen saturation
• Laboratory values- carbon dioxide [ Time Frame: 1 week post-CPB ]
  veno-arterial carbon dioxide difference is the carbon dioxide from the venous blood gas minus the carbon dioxide from the arterial blood gas.
• Laboratory values- oxygen content [ Time Frame: 1 week post-CPB ]
  arterial and venous oxygen content is the saturation from the arterial blood gas and the saturation from the venous blood gas
• Colloid/blood product volumes administered in the cardiovascular operating room [ Time Frame: intraoperative period ]
  volume in mililiters of crystalloids and colloids (albumin, fresh frozen plasma, packed red blood cells, and platelets) administered in the operating room
• Inotrope infusion doses [ Time Frame: 48 hours post-CPB ]
  incidence of low cardiac output syndrome based on inotropic support requirement in the post-operative period
• Inflammatory cytokines [ Time Frame: 48 hours post-CPB ]
  plasma will be collected and sent for inflammatory cytokine analysis at the following time points: pre-operative, 0 hour, 4 hour, 24 hour, and 48 hour post-cardiopulmonary bypass
• ACTH stimulation test [ Time Frame: 14 days post-CPB ]

  ACTH testing will be performed preoperative, immediately post-CPB, and prior to CICU discharge. This testing includes the following:

  Baseline ACTH and cortisol levels, administration of cosyntropin, 30 minutes post-cosyntropin cortisol level

Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: October 14, 2016
Date Started: July 2016
Date Completion: June 2018
Last Updated: November 3, 2016
Last Verified: November 2016