MedTrace Logo

Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

NCT03143348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2019-04-30

No results posted yet for this 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.

Conditions

  • Congenital Heart Defect
  • Cardiopulmonary Bypass
  • Inflammatory Response
  • Low Cardiac Output Syndrome
  • Inflammation

Interventions

PROCEDURE

Single blood draw

One blood draw of 0.5 ml volume prior to discharge

PROCEDURE

Multiple blood draws

Blood draw at 6 peri-operative time points.

PROCEDURE

Multiple blood draws

Blood draw at 7 peri-operative time points

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Hala Chaaban, MD · University of Oklahoma

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-04
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143348 on ClinicalTrials.gov