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Completed

NCT Number: NCT00934843

Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).

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Key information

Conditions

Congenital Heart Disease Cardiac Output, Low 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 Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

This study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB). The study will focus on neonates for a few reasons. Although their post-CPB clinical course is typically more severe and intensive care unit (ICU) care more prolonged than older children, their modes of morbidity are also well characterized. Further, the 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. The well characterized scenario of low cardiac output syndrome (LCOS) will be used as the primary endpoint, while a variety of secondary endpoints will be related to the biochemical anti-inflammatory effects of therapy, ICU care and late neurological outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Neonates Age </= 1 month
  • Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)
  • Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion criteria

  • Prematurity: </= 36 weeks post gestational age at time of surgery
  • Treatment with steroids, other than inhaled forms, in the two weeks 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 (e.g., gastrointestinal bleeding)
  • Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization
  • Inability to begin the pre-operative study drug at least 8 hours prior to surgery

Treatment and study plan

methylprednisolone (IVMP)

Drug

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive ONE doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP (2 dose steroid)to intraoperative IVMP alone (single dose steroid) on the inflammatory response to CPB cardiopulmonary bypass.

Other names: Solumedrol, Steroid, glucocorticoid

methylprednisolone (two doses IVMP)

Drug

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB)machine in the first month of life that receive TWO doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP to intraoperative IVMP alone on the inflammatory response to CPB cardiopulmonary bypass. The hypothesis is that neonates treated with preoperative IVMP as well as the standard intraoperative IVMP will have decreased production of pro-inflammatory cytokines.

Other names: Solumedrol, Steroid, glucocorticoid

Primary outcomes

  1. Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.

    Time frame: 36 hours

    The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.

Secondary outcomes

  1. Inotropic Score

    Time frame: over the first 36 hours after surgery

    The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.

  2. Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery

    Time frame: at 36 hours and 30 days

    Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery

  3. Urine Output

    Time frame: over 36 hours

    Total urine output in mL over the first 36 hours after cardiac surgery

  4. Total Intake/Output of Fluid

    Time frame: over 36 hours

    Total amount of all fluids in and out during the first 36 hours postoperatively in mL.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2009
Registry last updated
Dec 9, 2011

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.

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