Skip to main content
OpenTrials
Completed

NCT Number: NCT01579513

Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent inflammatory response secondary to the body's recognition of the abnormal environment of the heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney function after the heart surgery. This is turn can lead to longer times on the ventilator (breathing machine), the need for higher doses of heart medications, a longer stay in the intensive care unit and even death. This is particularly true in infants less than one month of age due to their size and the immaturity of their organs. The appreciation of the post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions directed at its reduction. No therapy has been recognized as the standard of care; however steroid therapy has been applied most often despite unclear evidence of a benefit. This study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorder of Fetus or Newborn Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Heart Defects, Congenital Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta/Emory University, Atlanta, Georgia, United States

Loading trial locations.

About this study

This study is a multi-institutional randomized double-blind placebo controlled trial of the use of glucocorticoids to improve the clinical course of neonates following cardiac surgery. Cardiopulmonary bypass (CPB) is critical to cardiac surgery, but the pathophysiologic processes engendered by CPB play an important role in post-operative recovery. The use, doses and schedule of glucocortiocoid administration to ameliorate these CPB induced processes is highly variable and without clear data to provide direction. The Primary Aim of this study is to compare the effects of intraoperative methylprednisolone to placebo on a composite morbidity-mortality outcome following neonatal CPB. Secondary Endpoints include: inotropic requirements, incidence of low cardiac output syndrome, fluid balance, ICU stay parameters, levels of inflammatory molecules, neuro-developmental outcomes, and safety parameters. The study will focus on neonates because their post-CPB clinical course is typically more severe, and that high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. Finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age < 1 month
  • Male and female patients who are scheduled to undergo cardiac surgery involving CPB

Exclusion criteria

  • Prematurity: < 37 weeks post gestational age at time of surgery
  • Treatment with intravenous steroids within the two days prior to scheduled surgery.
  • Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization.
  • Suspected infection that would contraindicate steroid use (eg - Herpes)
  • Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (eg - gastrointestinal bleeding).
  • Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization.

Treatment and study plan

methylprednisolone

Drug

Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Other names: Solulmedrol, Medrol, Corticosteroid, Steroid, Glucocorticoid

Placebo

Drug

Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.

Other names: Normal Saline

Primary outcomes

  1. Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population.

Secondary outcomes

  1. Duration of Mechanical Ventilation Post Cardiac Surgery.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    Amount of time on mechanical ventilation following cardiac surgery

  2. Intensive Care Unit Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    Amount of time in the intensive care unit following cardiac surgery

  3. Hospital Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

    Total duration of hospital stay following cardiac surgery

  4. Neurodevelopmental Outcome

    Time frame: 1 year

    Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2012
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.