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

September 27, 2007
September 1, 2010
September 2007
April 2010   (final data collection date for primary outcome measure)
A 25% additional decrease in IL-6 concentration change [ Time Frame: The First 24 hours of CRRT ]
Same as current
Complete list of historical versions of study NCT00537693 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cytokine Removal by CRRT in Pediatric Sepsis
Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Sepsis
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: 1
    CRRT via Convection
    Intervention: Procedure: Continuous Renal Replacement Therapy
  • Active Comparator: 2
    CRRT via Diffusion
    Intervention: Procedure: Continuous Renal Replacement Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00537693
H-21133
Not Provided
Not Provided
Sunnybrook Health Sciences Centre
Dialysis Solutions Inc.
Principal Investigator: Stuart Goldstein, MD Texas Children's Hospital
Sunnybrook Health Sciences Centre
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP