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NCT03143348 · ClinicalTrials.gov registry record
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
A clinical trial, sponsored by University of Oklahoma.
- Completed
- Registry status
- 38
- Enrollment target
NCT03143348: Completed study, sponsored by University of Oklahoma.
NCT03143348 is a clinical trial that has completed, run by University of Oklahoma. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03143348 has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Changes in markers of inflammation and cell injury (histones, IL-6, etc.) and correlation with patients who develop low cardiac output syndrome
Interventions
- PROCEDURE Single blood draw
- PROCEDURE Multiple blood draws
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-06-04 |
| Est. Completion | 2019-04-15 |
What the finished NCT03143348 record still lists
NCT03143348 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Single blood draw is the first listed.
NCT03143348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03143348 about?
NCT03143348 is a clinical study titled "Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass". 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 w...
What is the current status of trial NCT03143348?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2017-06-04. Estimated completion is 2019-04-15.
What interventions are being tested in trial NCT03143348?
The interventions under investigation include: Single blood draw (PROCEDURE), Multiple blood draws (PROCEDURE).
Who is sponsoring clinical trial NCT03143348?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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