Sepsis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Helen De Vos Children's Hospital | Grand Rapids | Michigan |
United States | Texas Childrens Hospital | Houston | Texas |
United States | All Children's Hospital | St. Petersburg | Florida |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Dialysis Solutions Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A 25% additional decrease in IL-6 concentration change | The First 24 hours of CRRT | ||
Secondary | Other cytokine removal rates | First 24 hours of CRRT | ||
Secondary | Cytokine absorption on the CRRT membrane | First 24 hours of CRRT | ||
Secondary | Hemodynamic parameters | First 24 hours of CRRT | ||
Secondary | Changes in serum cytokine concentrations and clearance | After crossover, from 24-48 hours | ||
Secondary | Changes in serum cytokine concentrations | From beginning to end of the study, independent of modality |
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