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

Completed

• Conditions: Cancer; Hematologic Disorders
• Interventions: Other: Catheter Resistance Monitoring

• Registration Number: NCT01737554
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Study Start: 2012-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Catheter Resistance Monitoring	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

Primary Outcome Measures

Name	Time	Method
Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD	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 Outcome Measures

Name	Time	Method
Attendance at each planned CRM visit	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.
The relationship between CRM results and occlusion or dysfunction	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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States