Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 5 - 24 |
| Updated: | 12/22/2016 |
| Start Date: | December 2012 |
| End Date: | September 2016 |
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
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.
(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.
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.
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.
- 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
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Joshua Wolf, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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