Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Completed

• Conditions: Inflammation; Congenital Heart Disease

• Registration Number: NCT05154864
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-11-08
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-13
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
Ventilation Index (VI)	Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.	Scale 0-40

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada