Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SBUF-SMUF 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
Intra-operative continuous ultrafiltration
|
Outcome Measures
Primary Outcome Measures
- Inflammatory Mediator Analysis [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]
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.
Secondary Outcome Measures
- Vasoactive-Ventilation-Renal (VVR) Score [Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.]
Scale 0-60
- Vasoactive-Inotrope Score (VIS) [Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.]
Scale 0-40
- Ventilation Index (VI) [Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.]
Scale 0-40
- Oxygenation Index (OI) [Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.]
Scale 0-20
- Ventilation Time [Through study completion, an average of 1 week.]
- Intensive Care Unit Length of Stay [Through study completion, an average of 1 week.]
Standardized Discharge Criteria
- Acute Kidney Injury [Through study completion, an average of 1 week.]
Kidney Disease Improving Global Outcomes criteria with Stages 1-3
Other Outcome Measures
- Arterial Blood Gas [Pre-specified time points: Pre-Sternotomy (20min), Post-Sternotomy (30 min), every 30 minutes during cardiopulmonary bypass, 0,12,24,48,72,96,120 hours post-ultrafiltration.]
- Red Blood Cell Transfusion [Measured through 24-hours post-operative]
volume in ml/kg
- Plasma Transfusion [Measured through 24-hours post-operative]
volume in ml/kg
- Platelet Transfusion [Measured through 24-hours post-operative]
volume in ml/kg
- Complete Blood Counts [Pre-specified time points: baseline, ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.]
- Total Chest Tube Output [Through study completion, an average of 1 week.]
volume in ml/kg
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
Sponsors and Collaborators
- IWK Health Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Bierer J, Henderson M, Stanzel R, Sett S, Horne D. Subzero balance - simple modified ultrafiltration (SBUF-SMUF) technique for pediatric cardiopulmonary bypass. Perfusion. 2021 Jun 18:2676591211027788. doi: 10.1177/02676591211027788. [Epub ahead of print]
- Bierer J, Stanzel R, Henderson M, Sett S, Horne D. Ultrafiltration in Pediatric Cardiac Surgery Review. World J Pediatr Congenit Heart Surg. 2019 Nov;10(6):778-788. doi: 10.1177/2150135119870176. Review.
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