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


N/A
5 Years
24 Years
Open (Enrolling)
Both
Cancer, Hematologic Disorders

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Trial Information

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


Inclusion Criteria:



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

- Age ≥5 years to <25 years.

- Single or double lumen tunneled CVAD (ports will not be eligible).

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Joshua Wolf, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

CARMA

NCT ID:

NCT01737554

Start Date:

December 2012

Completion Date:

February 2015

Related Keywords:

  • Cancer
  • Hematologic Disorders
  • Central venous access device
  • Catheter resistance monitoring
  • Hematologic Diseases

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794