N/A
N=40
Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Heart Disease Congenital Complex
Bottom Line
View on ClinicalTrials.gov: NCT01595386 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Nov 2015
Primary outcome: Primary: Incidence of Low Cardiac Output Syndrome (LCOS) — 57; 26 percentage of patients — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrocortisone (Drug); Normal Saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Low Cardiac Output Syndrome (LCOS) |
57; 26 | 0.049 sig |
| SECONDARY Mean Number of Days Subjects Alive and Ventilator Free |
24; 25 | 0.44 |
| SECONDARY Hospital Length of Stay |
13.5; 19 | 0.62 |
| SECONDARY Changes in Baseline Inflammatory Mediators |
4; 4.3; 225; 164; 53.5; 92.2 | <0.05 sig |
| SECONDARY Average Inotrope Score |
5.3; 4.7; 0; 4; 0; 0 | <0.05 sig |
| SECONDARY Fluid Balance |
-64; -114 | 0.04 sig |
| SECONDARY Changes in Baseline Arterial-venous Oxygen Saturation Difference |
14; 9.5 | 0.03 sig |
| SECONDARY Time Until First Extubation |
55; 51 | 0.7 |
| SECONDARY CICU Length of Stay |
162; 213 | 0.76 |
| SECONDARY Mortality |
14; 0 | 0.23 |
| SECONDARY ACTH Stimulation Test |
24.5; 31; 18.2; 23.3; 43.6; 47.1 | <0.05 sig |
Summary
This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.
Eligibility Criteria
Inclusion Criteria
- Neonate ( 28 days old at time of surgery whose repair dose not require CPB
Data sourced from ClinicalTrials.gov (NCT01595386). 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.