Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
Completed
Conditions studied: Congenital Heart Defect, Cardiopulmonary Bypass, Inflammatory Response, Low Cardiac Output Syndrome, Inflammation
In brief
This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery. This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.
Key facts
- Study ID
- NCT03143348
- Run by
- University of Oklahoma
- People needed
- 38
- Starts
- 2017-06-04
- Expected to finish
- 2019-04-15
- Last updated by the study team
- 2019-04-30
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants < 6 months of age
- Born at ≥ 36 weeks gestational age
- Birth weight ≥ 2.5 kilograms
- Postnatally confirmed congenital heart disease by echocardiogram
You may not qualify if…
- Requiring ≥ 2 vasopressors prior to surgery
- Preoperative proven sepsis within one week of surgery
- Prior surgery within one week of cardiac repair (except PA banding which is not excluded)
- Cardiac catheterization within one week of surgery
- Significant extra-cardiac anomalies that may impair organ function
Where it is running
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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