Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- A 25% additional decrease in IL-6 concentration change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 21 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
CRRT via Convection
Intervention: Continuous Renal Replacement Therapy (Procedure)
2
CRRT via Diffusion
Intervention: Continuous Renal Replacement Therapy (Procedure)
Outcomes
Primary Outcomes
A 25% additional decrease in IL-6 concentration change
Time Frame: The First 24 hours of CRRT
Secondary Outcomes
- 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)