Hemofilter Life Span, ECLS And/or CRRT

Completed

• Conditions: Kidney Diseases; Acute Injury of Kidney; Renal Failure; Neonatal Renal Disorder (Disorder); Renal Insufficiency

• Registration Number: NCT04193865
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Study Start: 2020-01-09
• Primary Completion: 2023-03-01
• Study Completion: 2024-03-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical Univeristy of South Carolina; 🇺🇸 Charleston, South Carolina, United States