Hemofilter Life Span, ECLS and/or CRRT

Study Overview
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Brief Summary
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The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

Detailed Description
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Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.

Official Title
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Hemofilter Life Span and Filtration of Inflammatory Markers in Patients Receiving Extracorporeal Life Support and/or Continuous Renal Replacement Therapy

Conditions
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Kidney Diseases, Acute Injury of Kidney, Renal Failure, Renal Insufficiency, Neonatal Renal Disorder (Disorder)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonatal or pediatric patients receiving ECLS (>2 kilograms and >34 weeks gestation) CRRT utilized during ECLS course For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria: Neonatal or pediatric patients receiving CRRT Exclusion criteria: -Those patients with inability or unwillingness of legal guardian/representative to give informed consent

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 17 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 |
| --- | --- |
| Extracorporeal Life Support with Renal Replacement Therapy<br>This cohort will include all subjects receiving extracorporeal life support with concurrent continuous renal replacement therapy. Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each participants's CRRT course. | |
| Renal Replacement Therapy<br>This cohort will include all subjects receiving continuous renal replacement therapy (no extracorporeal life support). Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each patient's CRRT course. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine concentrations over time (every 12 hours for the entire course of CRRT) | Quantify cytokine concentrations, specifically interferon (IFN)- γ, interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12p70, tumor necrosis factor (TNF)-α (all to result in concentrations in pg/ml), in pre-CRRT filter serum, post-CRRT filter serum, and ultrafiltrate (UF) using electrochemiluminescene assay and cytometric bead array and determine how age of the CRRT filter influences filtration of these cytokines. | Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal life support, Extracorporeal membrane oxygenation, Acute Kidney Injury, Renal replacement therapy, Renal Support therapy, Kidney support therapy