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NCT Number: NCT03143348

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 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.

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Key information

Conditions

Congenital Heart Defect Cardiac Output, Low Cardiopulmonary Bypass Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Inflammation Inflammatory Response Low Cardiac Output Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single blood draw

Procedure

One blood draw of 0.5 ml volume prior to discharge

Multiple blood draws

Procedure

Blood draw at 6 peri-operative time points.

Primary outcomes

  1. Biomarker levels and their relationship to LCOS

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

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

Secondary outcomes

  1. Change in level of inflammatory response

    Time frame: Baseline, up to 24 hours

    Changes in markers of inflammation and cell injury (IL-6, IL-8, etc.) in the peri-operative period (prior to surgery up to 24 hours postop)

  2. Length of mechanical ventilation

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

    Number of days on mechanical ventilation following day of surgery until the point of extubation

  3. Acute kidney injury

    Time frame: Participants will be followed for the first twenty four hours postoperatively

    Doubling of creatinine in first twenty four hours compared to preoperative levels

  4. Extracorporeal membrane oxygenation (ECMO)

    Time frame: First 48 hours postoperatively

    Whether or not patient requires ECMO cannulation

  5. ICU length of stay

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

    Number of days requiring pediatric/cardiac intensive care unit following day of surgery

  6. Hospital length of stay

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

    Number of hospital days patient requires following the day of surgery

  7. Mortality risk

    Time frame: PIM-2 calculated within one hour of admission to PICU and PRISM-3 calculated at 12 and 24 hours after PICU admission

    Pediatric risk of mortality-3 scale (PRISM-3) and pediatric index of mortality (PIM-2)

  8. Mortality

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

    Any type of death that occurs during patient's hospitalization

  9. Low cardiac output syndrome

    Time frame: Assessed at 48 hours postoperatively

    At least two of the following criteria at any post-operative time point within the first twenty four hours: (a) prolonged cap refill >3 sec, SBP <5th %ile for age and gender, low UOP <1 cc/kg/hr for at least 6 hr not responsive to diuretics, persistently elevated arterial lactate >2 and metabolic acidosis defined as an increase in the base deficit of >4, inotropic score >20, cardiac arrest within 48 hr after surgery, or the need for extracorporeal membrane oxygenation (ECMO) for hemodynamic instability within 48 hours postop

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard): an Observational Pilot Study

Acronym: ProCard

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 8, 2017
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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