Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents
NCT ID: NCT01737554
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2012-12-31
2016-09-30
Brief Summary
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There is a clear link between catheter occlusion and other serious complications including bloodstream infection and intravascular thrombosis.
There is evidence that catheter occlusion or dysfunction may be preceded by subclinical catheter narrowing, which could be detected by accurate measurement of catheter resistance.
This study aims to observe and describe the feasibility and results of catheter resistance monitoring (CRM) over time with the aim of prospectively identifying patients at high risk of catheter occlusion.
If CRM is feasible and proves to be sensitive and specific, it could provide an opportunity for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection or thrombosis.
Detailed Description
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Primary Objective
* To describe the feasibility of weekly CRM in children and adolescents treated at St. Jude.
Secondary Objectives
* To describe patient and caregiver adherence with weekly CRM in children and adolescents treated at St. Jude.
* To explore the correlation between results of CRM and catheter occlusion or dysfunction.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Participants include children with cancer and hematologic disorders who, as part of their standard clinical care, have a central venous access device (CVAD) used for infusion, withdrawal of blood, or hemodynamic monitoring.
Intervention: Catheter resistance monitoring
Catheter Resistance Monitoring
Weekly measurement of resistance to flow in the lumen(s) of a CVAD with the commercially available Alaris® Syringe Module IV pump. The aim is to identify an increase in resistance greater than normal variation. Inline pressure measurements will be recorded at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.
Interventions
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Catheter Resistance Monitoring
Weekly measurement of resistance to flow in the lumen(s) of a CVAD with the commercially available Alaris® Syringe Module IV pump. The aim is to identify an increase in resistance greater than normal variation. Inline pressure measurements will be recorded at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥5 years to \<25 years.
* Participant is using either a single or double lumen tunneled CVAD (ports will not be eligible) as part of standard clinical care.
* Participant anticipates being present weekly at SJCRH for at least 12 weeks
Exclusion Criteria
* Expected survival less than 12 weeks
* Past enrollment in the CaRMA study or past catheter resistance monitoring
5 Years
24 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Joshua Wolf, MBBS
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Wolf J, Tang L, Rubnitz JE, Brennan RC, Shook DR, Stokes DC, Monagle P, Curtis N, Worth LJ, Allison K, Sun Y, Flynn PM. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study. PLoS One. 2015 Aug 31;10(8):e0135904. doi: 10.1371/journal.pone.0135904. eCollection 2015.
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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CARMA
Identifier Type: -
Identifier Source: org_study_id