The Optimal Ultrafiltration Protocol in Pediatric Cardiac Surgery: An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Inflammatory Mediator Analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Inflammatory Mediator Analysis
时间窗: 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.
次要结局
- Oxygenation Index (OI)(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.)
- Vasoactive-Ventilation-Renal (VVR) Score(Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.)
- Vasoactive-Inotrope Score (VIS)(Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.)
- Intensive Care Unit Length of Stay(Through study completion, an average of 1 week.)
- Acute Kidney Injury(Through study completion, an average of 1 week.)
- Ventilation Index (VI)(Pre-specified time points: ICU admission, 12,24,48,72,96,120 hours post-ultrafiltration.)
研究者
Dr. David Horne
Congenital Cardiac Surgeon
IWK Health Centre