Clinical trial NCT01737554: Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents
Official title: Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Hematologic Disorders
Keywords: Central venous access device
Catheter resistance monitoring
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be drawn from current St. Jude patients who have a central venous access device already in place as part of their standard clinical care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD
timeFrame: Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter
Secondary outcomes:
measure: Attendance at each planned CRM visit
timeFrame: Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter
measure: The relationship between CRM results and occlusion or dysfunction
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Joshua Wolf, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.