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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

• Study Contact: Name: Kenreka Yeadon; Phone Number: 843-792-7965; Email: yeadon@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical Univeristy of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Heidi Murphy, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Acute Kidney Injury; Extracorporeal membrane oxygenation; Extracorporeal life support; Renal Support therapy; Kidney support therapy
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 00094177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No