CancerNCT01737554
Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents
An observational study of Cancer and Hematologic Disorders, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 24 years
- Conditions the study is for
- Cancer, Hematologic Disorders
- What is being tested?
- Catheter Resistance Monitoring
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Plan to remove CVAD within 12 weeks.
- Expected survival less than 12 weeks
- Past enrollment in the CaRMA study or past catheter resistance monitoring
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer, Hematologic Disorders
- Being tested
- Catheter Resistance Monitoring
- Keywords
- Central venous access device, Catheter resistance monitoring
- Medical subject headings
- Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Resistance MonitoringOther
Also called CRM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Catheter Resistance Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Wolf, MBBS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737554
- Sponsor's protocol ID
- CARMA
- Status last verified
- Dec 2016
- First submitted
- 27 Nov 2012
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26322512
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01737554
- Acronym / sponsor ID
- CARMA
- Conditions
- Cancer, Hematologic Disorders
- Keywords
- Central venous access device, Catheter resistance monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Catheter Resistance MonitoringParticipants 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 |
Who may qualify
- Ages
- 5 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Plan to remove CVAD within 12 weeks.
- Expected survival less than 12 weeks
- Past enrollment in the CaRMA study or past catheter resistance monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Resistance MonitoringAlso: CRMWeekly 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 | Participants |
Primary outcome
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
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.
2 secondary outcomes
Attendance at each planned CRM visit
Time frame: 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
Time frame: Up to 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Derived from this study: PubMed 26322512Wolf 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.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Wolf, MBBS principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hematologic Disorders, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.