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Completed

NCT Number: NCT04193865

Hemofilter Life Span, ECLS And/or CRRT

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.

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Key information

Conditions

Kidney Diseases Acute Injury of Kidney Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neonatal Renal Disorder (Disorder) Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

0 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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