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Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents

NCT01737554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2016-12-21

No results posted yet for this study

Summary

Catheter occlusion and dysfunction are common complications of central venous access device (CVAD) use in children with cancer and hematologic disorders. These events can lead to interruption of therapy and may require device removal and replacement. Attempts to clear occlusion can cause device fracture.

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.

Conditions

  • Cancer
  • Hematologic Disorders

Interventions

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Joshua Wolf, MBBS · St. Jude Children's Research Hospital

Eligibility

Min Age
5 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737554 on ClinicalTrials.gov