N/A
N=40
Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study
Congenital Heart Disease · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT05154864 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: Inflammatory Mediator C3a — 30 pg/ml
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SBUF-SMUF (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- IWK Health Centre
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Mediator C3a |
30 | — |
| PRIMARY Inflammatory Mediator C5a |
106.4 | — |
| PRIMARY Inflammatory Mediator IL-6 |
375.1 | — |
| PRIMARY Inflammatory Mediator IL-8 |
63.7 | — |
| SECONDARY Vasoactive-Ventilation-Renal Score |
19 | — |
| SECONDARY Vasoactive-Inotrope Score |
7 | — |
| SECONDARY Ventilation Index |
11 | — |
| SECONDARY Oxygenation Index |
2 | — |
| SECONDARY Ventilation Time |
19 | — |
| SECONDARY Intensive Care Unit Length of Stay |
62 | — |
| SECONDARY Acute Kidney Injury |
3 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05154864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.