Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Study Overview
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Brief Summary
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Infants and children undergoing cardiac surgery with cardiopulmonary bypass (CPB) can experience systemic inflammation that prolongs post-operative recovery. Ultrafiltration is an intra-opreative technique that is hypothesized to extract circulating inflammatory mediators during the CPB time. There have been only a few small studies looking at a limited number of inflammatory marker profiles in this context. Our institution uses an innovative form of ultrafiltration subzero-balance simple-modified ultrafiltration (SBUF-SMUF) throughout the entire CPB time. SBUF-SMUF has been our standard of care for the last 5 years. This observational seeks to describe the clinical and immunologic outcomes of infants and children undergoing cardiac surgery with CBP and SBUF-SMUF.

Official Title
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The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study

Conditions
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Congenital Heart Disease, Inflammation

Intervention / Treatment
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* Procedure: SBUF-SMUF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital cardiac patients (< 30kg) that have been consented to a planned cardiac surgery procedure requiring cardiopulmonary bypass at the IWK Health Centre. Patient or family consent to participate in the study. Exclusion Criteria: Patient or family refusal to participate. Known genetic syndrome with multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome. Known immunodeficiency syndrome or bone marrow pathology. Severe liver disease with abnormal synthetic liver function tests.

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SBUF-SMUF<br>All patients underwent standard of care cardiac surgery, cardiopulmonary bypass and SBUF-SMUF with effluent removal of 30 ml/kg/hr and physiologic solution replacement of 25ml/kg/hr. | Procedure: SBUF-SMUF<br>* Intra-operative continuous ultrafiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Mediator Analysis | Change in Concentrations of C1q, C2, C3, C3b, C4, C4b, C5, complement factor B, complement factor H, complement factor IC5a, CCL2 ,CCL3, CCL4, CCL5 (RANTES), CXCL1, CXCL2, CXCL10, GM-CSF, IL-1α, IL-1β, IL-1Ra, IL-2, IL-6, CXCL8 (IL-8), IL-10, IL-12 (p70), IL-17/IL-17A, IL-33, TNF (TNF-α), TRAIL, IFN-γ, E-Selectin, L-Selectin, P-Selectin, ICAM-1, VCAM-1, ET1. | Plasma and ultrafiltrate effluent at pre-specified time points: Pre-Sternotomy (20min), Post-Sternotomy (30 min), every 30 minutes during cardiopulmonary bypass, 0 hours post-ultrafiltration, 12 hours post-ultrafiltration, 24 hours post-ultrafiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoactive-Ventilation-Renal (VVR) Score | Scale 0-60 | Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration. | 
| Vasoactive-Inotrope Score (VIS) | Scale 0-40 | Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration. | 
| Ventilation Index (VI) | Scale 0-40 | Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration. | 
| Oxygenation Index (OI) | Scale 0-20 | Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration. | 
| Ventilation Time |  | Through study completion, an average of 1 week. | 
| Intensive Care Unit Length of Stay | Standardized Discharge Criteria | Through study completion, an average of 1 week. | 
| Acute Kidney Injury | Kidney Disease Improving Global Outcomes criteria with Stages 1-3 | Through study completion, an average of 1 week. |