Cytokine Removal by CRRT in Pediatric Sepsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion

Conditions
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Sepsis

Intervention / Treatment
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* Procedure: Continuous Renal Replacement Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CRRT via Convection | Procedure: Continuous Renal Replacement Therapy<br>* 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.<br>|
| Active Comparator: 2<br>CRRT via Diffusion | Procedure: Continuous Renal Replacement Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 25% additional decrease in IL-6 concentration change |  | The First 24 hours of CRRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion