Hemofilter Life Span, ECLS And/or CRRT

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04193865

Enrollment

Registered

2019-12-10

Start date

2020-01-09

Completion date

2024-03-25

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Extracorporeal life support, Extracorporeal membrane oxygenation, Acute Kidney Injury, Renal replacement therapy, Renal Support therapy, Kidney support therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cytokine concentrations over time (every 12 hours for the entire course of CRRT)	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.

Countries

United States

Outcome results