The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. The study will focused on pediatric participants who require open heart surgery to repair certain types holes in the heart.
Typically for pediatric patients, the cardiopulmonary bypass pump is "primed" (filled) with donated blood products. This project is going to test if the exposure to these blood products causes inflammation. Patients experience significant inflammation (swelling) after undergoing cardiopulmonary bypass. This inflammation can interfere and slow down the patient's recovery from cardiac surgery. With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.
The investigators are also studying if using non-blood fluids to fill the bypass pump reduces bypass associated side effects.
The investigators are also trying to understand how the inflammation starts. The investigators also want to study genetic material called DNA that is collected from a person's blood. Instructions for the body are contained in parts of DNA called genes. Genes determine things like hair and eye color. The investigator hope by studying genes the investigator can learn more about the inflammation that occurs after heart surgery, but the investigators might use participant's genetic information to study other diseases or conditions other the inflammation that occurs after heart surgery.
The investigators will be studying the recovery of 60 participants between 1 month to 18 months of age who require open heart surgery to repair ventricular septal defects (VSDs), a congenital heart defect where there a hole between the lower chambers of the heart.
Participants will:
Allow for information about how the participants recover from surgery to be collected.
Allow blood samples during and after surgery to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).
Weight between 5-10kg
Age 1-18 months
Requiring cardiopulmonary bypass as part of clinically indicated surgery
Surgery performed by Dr. Bohuta or Dr. Greene
Hemoglobin/hematocrit too low for clear CPB prime (post-dilution Hct <24%)
Pre-operative ECMO support
Active infection
Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.)
Parallel
Clear priming of the bypass pump
Procedure/SurgeryThe intervention is priming the pump with non-blood products.
Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in TNF-α fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Changes in protein expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed ELISA to assess changes in TNF-α fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
Changes in RNA expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in IL8 fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Changes in protein expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via ELISA to assess changes in IL8 fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
Time to extubation
Clinical data will be collected to measure the number of hours and minutes post-surgery until participants are extubated.
Peak lactic acid levels over the first 24 hours post-surgery
Clinical laboratory data will be reviewed to identify the highest lactic acid (Normal: ≤2 mmol/L) value recorded within the first 24 hours after surgery. Lactic acid levels (measured in mmol/L) indicate how well the body is delivering oxygen to tissues after surgery.
Vasoactive-inotropic score over the first 24 hours post-surgery
Clinical data will be collected to determine how much ionotropic support is needed during the first 24 hours after surgery. The vasoactive-inotropic score typically range from 0 to 15, with higher scores indicating a greater need for inotropic support and worse outcomes, and values above 15 are considered atypical.
Length of hospital stay post-surgery
Clinical information will be collected from participants' medical charts to measure the length of hospital stay (in days) after surgery.
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