Clinical trial · Observational
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematologic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Catheter Resistance Monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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
- interventionNames
- Other: Catheter Resistance Monitoring
Primary outcomes (1)
- measure
- Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD
- timeFrame
- Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWolf 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