Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

Inflammation Clinical Trial

— ProCard  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143348
• Other study ID #: 7676
• Status: Completed
• Start date: June 4, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Single blood draw
One blood draw of 0.5 ml volume prior to discharge
• Multiple blood draws
Blood draw at 6 peri-operative time points.
• Multiple blood draws
Blood draw at 7 peri-operative time points

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in level of inflammatory response	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)	Baseline, up to 24 hours
Secondary	Length of mechanical ventilation	Number of days on mechanical ventilation following day of surgery until the point of extubation	Participants will be followed throughout hospital course, maximum length of follow-up one year
Secondary	Acute kidney injury	Doubling of creatinine in first twenty four hours compared to preoperative levels	Participants will be followed for the first twenty four hours postoperatively
Secondary	Extracorporeal membrane oxygenation (ECMO)	Whether or not patient requires ECMO cannulation	First 48 hours postoperatively
Secondary	ICU length of stay	Number of days requiring pediatric/cardiac intensive care unit following day of surgery	Participants will be followed throughout PICU/CVICU stay, maximum length of follow-up one year
Secondary	Hospital length of stay	Number of hospital days patient requires following the day of surgery	Participants will be followed throughout entire hospital course, maximum length of follow-up one year
Secondary	Mortality risk	Pediatric risk of mortality-3 scale (PRISM-3) and pediatric index of mortality (PIM-2)	PIM-2 calculated within one hour of admission to PICU and PRISM-3 calculated at 12 and 24 hours after PICU admission
Secondary	Mortality	Any type of death that occurs during patient's hospitalization	Participants will be followed throughout hospital course, maximum length of follow-up one year
Secondary	Low cardiac output syndrome	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	Assessed at 48 hours postoperatively