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Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00934843
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : December 9, 2011
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Disorder of Fetus or Newborn Drug: methylprednisolone (IVMP) Drug: methylprednisolone (two doses IVMP) Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single dose steroid
Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose intravenous methylprednisolone (IVMP) prior to heart surgery.
 Drug: methylprednisolone (IVMP)
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
Experimental: Two Dose steroid
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.
 Drug: methylprednisolone (two doses IVMP)
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934843


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Eric M Graham, MD Medical University of South Carolina
More Information
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Publications:
Friedman WF. Congenital heart disease in infancy and childhood. Heart Disease - A Textbook of Cardiovascular Medicine. 4th ed. Philadelphia, PA. W.B. Saunders Co.; 1992. p. 894.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00934843    
Other Study ID Numbers: HR 17030
First Posted: July 8, 2009    Key Record Dates
Results First Posted: December 9, 2011
Last Update Posted: December 9, 2011
Last Verified: September 2011
Keywords provided by Medical University of South Carolina:
Cardiopulmonary Bypass (CPB)
System Inflammatory Response
Low Cardiac Output Syndrome (LCOS) in Neonates
Methylprednisolone
 Cardiopulmonary Bypass (CPB) in Neonates
Glucocorticoid Use in Neonatal Cardiac Surgery
Steroid
Additional relevant MeSH terms:
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Fetal Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Pregnancy Complications
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
 Glucocorticoids
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents