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Clinical Trials/NCT04193865
NCT04193865
Completed
Not Applicable

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

Medical University of South Carolina1 site in 1 country10 target enrollmentJanuary 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Diseases
Sponsor
Medical University of South Carolina
Enrollment
10
Locations
1
Primary Endpoint
Cytokine concentrations over time (every 12 hours for the entire course of CRRT)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
January 9, 2020
End Date
March 25, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cytokine concentrations over time (every 12 hours for the entire course of CRRT)

Time Frame: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months

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.

Study Sites (1)

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