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Cytokine Removal by CRRT in Pediatric Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537693
First Posted: October 1, 2007
Last Update Posted: September 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dialysis Solutions Inc.
Information provided by:
Sunnybrook Health Sciences Centre
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

Resource links provided by NLM:


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
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537693


Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30303
United States, Michigan
Helen De Vos Children's Hospital
Grand Rapids, Michigan, United States, 49503
United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Dialysis Solutions Inc.
Investigators
Principal Investigator: Stuart Goldstein, MD Texas Children's Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00537693     History of Changes
Other Study ID Numbers: H-21133
First Submitted: September 27, 2007
First Posted: October 1, 2007
Last Update Posted: September 2, 2010
Last Verified: September 2010

Keywords provided by Sunnybrook Health Sciences Centre:
Continuous Renal Replacement Therapy (CRRT)
Sepsis
Convection
Diffusion

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes