Sepsis
Conditions
Keywords
Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion
Brief summary
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.
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.
Interventions
PROCEDUREContinuous 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.
Sponsors
Dialysis Solutions Inc.
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 25% additional decrease in IL-6 concentration change | The First 24 hours of CRRT |
Secondary
| Measure | Time frame |
|---|---|
| Other cytokine removal rates | First 24 hours of CRRT |
| Cytokine absorption on the CRRT membrane | First 24 hours of CRRT |
| Hemodynamic parameters | First 24 hours of CRRT |
| Changes in serum cytokine concentrations and clearance | After crossover, from 24-48 hours |
| Changes in serum cytokine concentrations | From beginning to end of the study, independent of modality |
Countries
United States
Outcome results
None listed