Cytokine Removal by CRRT in Pediatric Sepsis
1 other identifier
interventional
40
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable sepsis
Started Sep 2007
Typical duration for not_applicable sepsis
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedSeptember 2, 2010
September 1, 2010
2.6 years
September 27, 2007
September 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A 25% additional decrease in IL-6 concentration change
The First 24 hours of CRRT
Secondary Outcomes (5)
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
Study Arms (2)
1
ACTIVE COMPARATORCRRT via Convection
2
ACTIVE COMPARATORCRRT via Diffusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with documented sepsis or suspected SIRS
- Patients initiating CRRT
- Age 1 to 21 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Dialysis Solutions Inc.collaborator
Study Sites (5)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30303, United States
Helen De Vos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Texas Childrens Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Goldstein, MD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 27, 2007
First Posted
October 1, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2010
Study Completion
May 1, 2010
Last Updated
September 2, 2010
Record last verified: 2010-09