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Cytokine Removal by CRRT in Pediatric Sepsis

This study has been completed.
Sponsor:
Collaborator:
Dialysis Solutions Inc.
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00537693
First received: September 27, 2007
Last updated: September 1, 2010
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00537693     History of Changes
Other Study ID Numbers: H-21133
Study First Received: September 27, 2007
Last Updated: September 1, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014