Cytokine Removal by CRRT in Pediatric Sepsis - Full Text View

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre Dialysis Solutions Inc.
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00537693

Purpose

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.

Condition	Intervention
Sepsis	Procedure: Continuous Renal Replacement Therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

A 25% additional decrease in IL-6 concentration change [ Time Frame: The First 24 hours of CRRT ]

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537693

Contacts

Contact: Stuart Goldstein		slgoldst@TexasChildrensHospital.org
Contact: Annabelle Chua		anchua@TexasChildresnHospital.org

Locations

United States, District of Columbia
Children's National Medical Center	Recruiting
Washington, District of Columbia, United States, 20010
Sub-Investigator: Douglas Silverstein, MD
United States, Florida
All Children's Hospital	Recruiting
St. Petersburg, Florida, United States, 33701
Sub-Investigator: Francisco Flores, MD
United States, Georgia
Children's Healthcare of Atlanta	Recruiting
Atlanta, Georgia, United States, 30303
Sub-Investigator: James Fortenberry, MD
Sub-Investigator: Matthew Paden, MD
United States, Michigan
Helen De Vos Children's Hospital	Recruiting
Grand Rapids, Michigan, United States, 49503
Sub-Investigator: Timothy Bunchman, MD
Sub-Investigator: Richard Hackbarth, MD
United States, Texas
Texas Childrens Hospital	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Stuart Goldstein, MD
Sub-Investigator: Annabelle Chua, MD
Sub-Investigator: Laura Loftis, MD

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Dialysis Solutions Inc.

Investigators

Principal Investigator:

Stuart Goldstein, MD

Texas Children's Hospital

More Information

No publications provided

Study ID Numbers:	H-21133
Study First Received:	September 27, 2007
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00537693 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sunnybrook Health Sciences Centre:

Continuous Renal Replacement Therapy (CRRT)
Sepsis
Convection
Diffusion

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on September 11, 2009