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

NCT01737554 | Completed

• 1 other identifier: CARMA
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Hematologic Disorders

Keywords

Central venous access device; Catheter resistance monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Attendance at each planned CRM visit

  Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter

• The relationship between CRM results and occlusion or dysfunction

  Up to 15 weeks

Study Arms (1)

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

Interventions

Catheter Resistance Monitoring OTHER

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.

Also known as: CRM

Participants

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Plan to remove CVAD within 12 weeks.
• Expected survival less than 12 weeks
• Past enrollment in the CaRMA study or past catheter resistance monitoring

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• 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.

  PMID: 26322512 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Joshua Wolf, MBBS

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

US (1)