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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal Life Support with Renal Replacement Therapy | 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 | 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. |
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| 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 |
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Inclusion Criteria:
Exclusion criteria:
-Those patients with inability or unwillingness of legal guardian/representative to give informed consent
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Both male and female neonatal (aged 0-28 days of life) and pediatric (children aged 29 days-17 years) patients receiving ECLS will be eligible. The study team will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS).
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Murphy, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univeristy of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D052801 | Male Urogenital Diseases |