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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01737554
First received: November 27, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cancer
Hematologic Disorders
Other: Catheter Resistance Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD [ Time Frame: Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter ] [ Designated as safety issue: No ]
    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:
  • Attendance at each planned CRM visit [ Time Frame: Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 15 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 35
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants

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

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.
Other Name: CRM

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

Ages Eligible for Study:   5 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737554

Contacts
Contact: Joshua Wolf, MBBS 866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Joshua Wolf, MBBS    866-278-5833    info@stjude.org   
Principal Investigator: Joshua Wolf, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Joshua Wolf, MBBS St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01737554     History of Changes
Other Study ID Numbers: CARMA
Study First Received: November 27, 2012
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Central venous access device
Catheter resistance monitoring

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014