Cytokine Removal by CRRT in Pediatric Sepsis

Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

This pilot study will compare the effect of diffusive versus convective Continuous Renal Replacement Therapy (CRRT) in children with sepsis who require CRRT.

The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive CRRT modality.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Procedure: Continuous Renal Replacement Therapy

Detailed Description

The purpose of this study is to test the hypothesis that convective forms of Continuous Renal Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT modality.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • All Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Children's Healthcare of Atlanta
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Helen De Vos Children's Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with documented sepsis or suspected SIRS
• Patients initiating CRRT
• Age 1 to 21 years

Exclusion Criteria:

• Patients on ECMO
• Patients receiving concomitant plasma exchange
• Cardiopulmonary bypass procedure within 96 hours of CRRT
• Patients with new onset acute leukemia
• Patients with active autoimmune disease
• Ungrafted stem cell transplant recipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; CRRT via Convection	Procedure: Continuous Renal Replacement Therapy; Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.
Active Comparator: 2; CRRT via Diffusion	Procedure: Continuous Renal Replacement Therapy; Patients will be randomized to either arm for the first 24 hours of the study and then crossover to the second arm for the second 24 hours of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A 25% additional decrease in IL-6 concentration change	The First 24 hours of CRRT

Secondary Outcome Measures

Outcome Measure	Time Frame
Other cytokine removal rates	First 24 hours of CRRT
Cytokine absorption on the CRRT membrane	First 24 hours of CRRT
Hemodynamic parameters	First 24 hours of CRRT
Changes in serum cytokine concentrations and clearance	After crossover, from 24-48 hours
Changes in serum cytokine concentrations	From beginning to end of the study, independent of modality

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Dialysis Solutions Inc.
• Investigators: Principal Investigator: Stuart Goldstein, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 27, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (Estimate): October 1, 2007

Study Record Updates

• Last Update Posted (Estimate): September 2, 2010
• Last Update Submitted That Met QC Criteria: September 1, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Sepsis; Diffusion; Continuous Renal Replacement Therapy (CRRT); Convection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: H-21133