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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737554
• Other study ID #: CARMA
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: December 20, 2016
• Start date: December 2012
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 24 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Hematologic Diseases
• Hematologic Disorders

Intervention

Other:
• Catheter Resistance Monitoring
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD	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.	Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter	No
Secondary	Attendance at each planned CRM visit	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.	Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter	No
Secondary	The relationship between CRM results and occlusion or dysfunction	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.	Up to 15 weeks	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital