Cytokine Removal by CRRT in Pediatric Sepsis

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Procedure: Continuous Renal Replacement Therapy

• Registration Number: NCT00537693
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-10-01
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Continuous Renal Replacement Therapy	CRRT via Convection
2	Continuous Renal Replacement Therapy	CRRT via Diffusion

Primary Outcome Measures

Name	Time	Method
A 25% additional decrease in IL-6 concentration change	The First 24 hours of CRRT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Helen De Vos Children's Hospital; 🇺🇸 Grand Rapids, Michigan, United States

All Children's Hospital; 🇺🇸 St. Petersburg, Florida, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States