Hemofilter Life Span, ECLS and/or CRRT

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193865
• Other study ID #: 00094177
• Status: Completed
• Start date: January 9, 2020
• Est. completion date: March 25, 2024

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 25, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Medical Univeristy of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine concentrations over time (every 12 hours for the entire course of CRRT)	Quantify cytokine concentrations, specifically interferon (IFN)- ?, interleukin (IL)-1ß, IL-6, IL-8, IL-10, IL-12p70, tumor necrosis factor (TNF)-a (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