Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

NCT ID: NCT03143348

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-04
• Study Completion Date: 2019-04-15

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.

Detailed Description

This is a minimal risk observational study looking at markers of inflammation and cell injury in the bloodstream of babies with congenital heart disease, with a particular emphasis on whether these markers can predict low cardiac output syndrome in infants who undergo heart-lung bypass. Low cardiac output syndrome is a common postoperative complication marked by poor blood flow to the body affecting nearly 1/3 of infants post-bypass and is associated with significant morbidity and mortality.

Babies not requiring surgery will serve as the control group. Infants in group 1 will have 0.5 ml of blood drawn prior to discharge. This will be scavenged from the laboratory when possible. Infants in groups 2 and 3 will require serial blood draws over peri-operative time points each in the volume of 0.5 ml.

Group 2:

T0 = Before surgery (in the OR) T1 = After chest closure or end of case (in the OR) T2 = On admission to the pediatric intensive care unit T3 = Timed 4-6 hours after the time of admission T4 = Timed 12 hours (+/- 1 hour) after the time of admission T5 = Timed 24 hours (+/-1 hour) after the time of admission

Group 3:

T0 =Pre-cardiopulmonary bypass to be obtained in the operating room just prior to surgery T1 = After going on bypass (but prior to modified ultrafiltration) T2 = After modified ultrafiltration T3 = On admission to the pediatric intensive care unit T4 = Timed 4-6 hours after the time of admission T5 = Timed 12 hours (+/- 1 hour) after the time of admission T6 = Timed 24 hours (+/-1 hour) after the time of admission

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Control/Nonsurgical

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

Single blood draw

Intervention Type: PROCEDURE

One blood draw of 0.5 ml volume prior to discharge

Surgery w/o bypass

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

Multiple blood draws

Intervention Type: PROCEDURE

Blood draw at 6 peri-operative time points.

Surgery w/ bypass

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

Multiple blood draws

Intervention Type: PROCEDURE

Blood draw at 7 peri-operative time points

Interventions

Single blood draw

One blood draw of 0.5 ml volume prior to discharge

Intervention Type: PROCEDURE

Multiple blood draws

Blood draw at 6 peri-operative time points.

Intervention Type: PROCEDURE

Multiple blood draws

Blood draw at 7 peri-operative time points

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Infants < 6 months of age
• Born at ≥ 36 weeks gestational age
• Birth weight ≥ 2.5 kilograms
• Postnatally confirmed congenital heart disease by echocardiogram

Exclusion Criteria

• 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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hala Chaaban, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

7676

Identifier Type: -

Identifier Source: org_study_id