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

St. Jude Children's Research Hospital

Status: Completed

Conditions: Hematologic Disorders; Cancer

Treatments: Other: Catheter Resistance Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT01737554

CARMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 5 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Participants

Description:

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

Treatment:

Other: Catheter Resistance Monitoring