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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre Dialysis Solutions Inc. |
Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00537693 |
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 |
MedlinePlus related topics: | Sepsis |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
1: Active Comparator
CRRT via Convection
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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.
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2: Active Comparator
CRRT via Diffusion
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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.
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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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stuart Goldstein | slgoldst@TexasChildrensHospital.org | |
Contact: Annabelle Chua | anchua@TexasChildresnHospital.org |
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 |
Sunnybrook Health Sciences Centre |
Dialysis Solutions Inc. |
Principal Investigator: | Stuart Goldstein, MD | Texas Children's Hospital |
Study ID Numbers: | H-21133 |
First Received: | September 27, 2007 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00537693 |
Health Authority: | United States: Institutional Review Board |
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