N/A
Completed N=40
Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass
Heart Disease Congenital Complex
Source: ClinicalTrials.gov NCT01595386 ↗
Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Nov 2015
Primary outcomePrimary: Incidence of Low Cardiac Output Syndrome (LCOS) — 57; 26 percentage of patients — p=0.049
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.
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 |
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. Informational only — not medical advice.