Hemofilter Life Span, ECLS and/or CRRT

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04193865

Collaborator

Baxter Healthcare Corporation (Industry)

Enrollment

Location

35.7

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases Acute Injury of Kidney Renal Failure Renal Insufficiency 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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 9, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 17 Years

Sexes Eligible for Study:

All

Accepts 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