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Completed

NCT Number: NCT01737554

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

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.

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Key information

Conditions

Cancer Hematologic Diseases Hematologic Disorders Hemic and Lymphatic Diseases Neoplasms

Age range

5 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

Weekly measurement of catheter resistance will be determined using the Alaris® Syringe Module (Carefusion Inc., San Diego, USA), a commercially available, FDA-approved intravenous (IV) pump which is able to deliver accurate flow-rates and obtain accurate pressure measurements. The inline pressure will be measured at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving treatment for any disease at St. Jude Children's Research Hospital (SJCRH).
  • 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

  • Plan to remove CVAD within 12 weeks.
  • Expected survival less than 12 weeks
  • Past enrollment in the CaRMA study or past catheter resistance monitoring

Treatment and study plan

Catheter Resistance Monitoring

Other

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 names: CRM

Primary outcomes

  1. Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD

    Time frame: Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter

    To describe the feasibility of CRM in children and adolescents treated at St. Jude, the proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD will be recorded for each participant, and summary statistics, including median, range and standard deviation will be reported for the study population.

Secondary outcomes

  1. Attendance at each planned CRM visit

    Time frame: Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter

    To describe patient and caregiver adherence with weekly CRM in children and adolescents treated at St. Jude, attendance at each planned CRM visit will be recorded. Summary statistics for proportion of planned visits attended for each participant, including median, range and standard deviation will be reported for the study population.

  2. The relationship between CRM results and occlusion or dysfunction

    Time frame: Up to 15 weeks

    To explore the correlation between the results of CRM and catheter occlusion or dysfunction in children and adolescents, the relationship between CRM results and occlusion or dysfunction will be described.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 29, 2012
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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