Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

NCT03143348 | Completed

• 1 other identifier: 7676
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Biomarker levels and their relationship to LCOS

  Changes in markers of inflammation and cell injury (histones, IL-6, etc.) and correlation with patients who develop low cardiac output syndrome

  Baseline level and described time points over the first twenty-four hours postoperatively

Secondary Outcomes (9)

• Change in level of inflammatory response

  Baseline, up to 24 hours

• Length of mechanical ventilation

  Participants will be followed throughout hospital course, maximum length of follow-up one year

• Acute kidney injury

  Participants will be followed for the first twenty four hours postoperatively

• Extracorporeal membrane oxygenation (ECMO)

  First 48 hours postoperatively

• ICU length of stay

  Participants will be followed throughout PICU/CVICU stay, maximum length of follow-up one year

Study Arms (3)

Control/Nonsurgical

Infants with postnatally confirmed acyanotic congenital heart disease not expected to require surgery in the first six months of life.

Procedure: Single blood draw

Surgery w/o bypass

Infants with postnatally confirmed congenital heart disease requiring cardiac surgery without cardiopulmonary bypass.

Procedure: Multiple blood draws

Surgery w/ bypass

Infants with postnatally confirmed congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.

Procedure: Multiple blood draws

Interventions

Single blood draw PROCEDURE

One blood draw of 0.5 ml volume prior to discharge

Control/Nonsurgical

Multiple blood draws PROCEDURE

Blood draw at 6 peri-operative time points.

Surgery w/o bypass

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants \<6 months of age with congenital heart disease at OU Children's Hospital

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Cardiac Output, Low; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hala Chaaban, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: May 8, 2017
• Study Start: June 4, 2017
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)