Back to resultsCytokine Removal by CRRT in Pediatric Sepsis
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Renal Replacement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion
Eligibility Criteria
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
Sites / Locations
- Children's National Medical Center
- All Children's Hospital
- Children's Healthcare of Atlanta
- Helen De Vos Children's Hospital
- Texas Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
CRRT via Convection
CRRT via Diffusion
Outcomes
Primary Outcome Measures
A 25% additional decrease in IL-6 concentration change
Secondary Outcome Measures
Other cytokine removal rates
Cytokine absorption on the CRRT membrane
Hemodynamic parameters
Changes in serum cytokine concentrations and clearance
Changes in serum cytokine concentrations
Full Information
NCT ID
NCT00537693
First Posted
September 27, 2007
Last Updated
September 1, 2010
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Dialysis Solutions Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00537693
Brief Title
Cytokine Removal by CRRT in Pediatric Sepsis
Official Title
Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Dialysis Solutions Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
CRRT via Convection
Arm Title
2
Arm Type
Active Comparator
Arm Description
CRRT via Diffusion
Intervention Type
Procedure
Intervention Name(s)
Continuous Renal Replacement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
A 25% additional decrease in IL-6 concentration change
Time Frame
The First 24 hours of CRRT
Secondary Outcome Measure Information:
Title
Other cytokine removal rates
Time Frame
First 24 hours of CRRT
Title
Cytokine absorption on the CRRT membrane
Time Frame
First 24 hours of CRRT
Title
Hemodynamic parameters
Time Frame
First 24 hours of CRRT
Title
Changes in serum cytokine concentrations and clearance
Time Frame
After crossover, from 24-48 hours
Title
Changes in serum cytokine concentrations
Time Frame
From beginning to end of the study, independent of modality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Goldstein, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Helen De Vos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Cytokine Removal by CRRT in Pediatric Sepsis
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