SepsisNCT00537693
Cytokine Removal by CRRT in Pediatric Sepsis
A study testing Continuous Renal Replacement Therapy in people with Sepsis, run by Sunnybrook Health Sciences Centre at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Continuous Renal Replacement Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2007to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with documented sepsis or suspected SIRS
- Patients initiating CRRT
- Age 1 to 21 years
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30303
Helen De Vos Children's Hospital
Grand Rapids, Michigan, 49503
Texas Childrens Hospital
Houston, Texas, 77030
All Children's Hospital
St. Petersburg, Florida, 33701
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Continuous Renal Replacement Therapy
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Renal Replacement TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CRRT via Convection Receives: Procedure: Continuous Renal Replacement Therapy |
| 2 | Active comparator | CRRT via Diffusion Receives: Procedure: Continuous Renal Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 25% additional decrease in IL-6 concentration change
Measured: The First 24 hours of CRRT
Secondary outcomes (5)
Other cytokine removal rates
Measured: First 24 hours of CRRT
Cytokine absorption on the CRRT membrane
Measured: First 24 hours of CRRT
Hemodynamic parameters
Measured: First 24 hours of CRRT
Changes in serum cytokine concentrations and clearance
Measured: After crossover, from 24-48 hours
Changes in serum cytokine concentrations
Measured: From beginning to end of the study, independent of modality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Solutions Inc.
- Investigators
- Stuart Goldstein, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537693
- Sponsor's protocol ID
- H-21133
- Status last verified
- Sep 2010
- First submitted
- 27 Sep 2007
- Last updated
- 2 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Removal by CRRT in Pediatric Sepsis: A Comparison of Convection Versus Diffusion
- ClinicalTrials.gov ID
- NCT00537693
- Acronym / sponsor ID
- H-21133
- Conditions
- Sepsis
- Keywords
- Continuous Renal Replacement Therapy (CRRT), Sepsis, Convection, Diffusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Dialysis Solutions Inc.
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Continuous Renal Replacement TherapyCRRT via Convection |
| 2 | Active comparator | Procedure: Continuous Renal Replacement TherapyCRRT via Diffusion |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with documented sepsis or suspected SIRS
- Patients initiating CRRT
- Age 1 to 21 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Renal Replacement TherapyPatients 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. | Procedure or surgery | 1, 2 |
Primary outcome
A 25% additional decrease in IL-6 concentration change
Time frame: The First 24 hours of CRRT
5 secondary outcomes
Other cytokine removal rates
Time frame: First 24 hours of CRRT
Cytokine absorption on the CRRT membrane
Time frame: First 24 hours of CRRT
Hemodynamic parameters
Time frame: First 24 hours of CRRT
Changes in serum cytokine concentrations and clearance
Time frame: After crossover, from 24-48 hours
Changes in serum cytokine concentrations
Time frame: From beginning to end of the study, independent of modality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
Related trials for Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Goldstein, MD principal investigator
Baylor College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Renal Replacement Therapy in people with Sepsis, run by Sunnybrook Health Sciences Centre at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 25% additional decrease in IL-6 concentration change (time frame: The First 24 hours of CRRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2010.