N/A
Completed N=77
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Heart Failure · Disorder of Fetus or Newborn
Source: ClinicalTrials.gov NCT00934843 ↗
Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Dec 2011
Primary outcomePrimary: 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. — 17; 15 participants — p=0.35
Summary
Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
17; 15 | 0.35 |
| SECONDARY Inotropic Score |
14.4; 15.0 | 0.43 |
| SECONDARY Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery |
1; 0 | — |
| SECONDARY Urine Output |
498; 453 | 0.052 |
| SECONDARY Total Intake/Output of Fluid |
575; 586; 600; 558 | 0.047 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00934843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.