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Trial record 2 of 6 for:    Congenital Heart Defects, Multiple Types, 6

Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard)

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ClinicalTrials.gov Identifier: NCT03143348
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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.


Condition or disease Intervention/treatment
Congenital Heart Defect Cardiopulmonary Bypass Inflammatory Response Low Cardiac Output Syndrome Inflammation Procedure: Single blood draw Procedure: Multiple blood draws

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


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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass (ProCard): an Observational Pilot Study
Actual Study Start Date : June 4, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Group/Cohort Intervention/treatment
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
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.
Procedure: Multiple blood draws
Blood draw at 6 peri-operative time points.

Surgery w/ bypass
Infants with postnatally confirmed congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.
Procedure: Multiple blood draws
Blood draw at 7 peri-operative time points




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants <6 months of age with congenital heart disease at OU Children's Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143348


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Hala Chaaban, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03143348     History of Changes
Other Study ID Numbers: 7676
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiac Output, Low
Inflammation
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Signs and Symptoms