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

20 december 2016 uppdaterad av: St. Jude Children's Research Hospital

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

10

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38105
        • St. Jude Children's Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 år till 24 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Övrig: 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.
Andra namn:
  • CRM

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of attended CRM visits which produce usable resistance data for all lumens of the CVAD
Tidsram: 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.
Weekly for 12 weeks from study entry or until discontinuation of CRM, whichever is shorter

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Attendance at each planned CRM visit
Tidsram: Weekly for 12 weeks or until discontinuation of CRM for a prescribed reason, whichever is shorter
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.
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
Tidsram: Up to 15 weeks
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.
Up to 15 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

St. Jude Children's Research Hospital

Utredare

  • Huvudutredare: Joshua Wolf, MBBS, St. Jude Children's Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2012

Primärt slutförande (Faktisk)

1 september 2016

Avslutad studie (Faktisk)

1 september 2016

Studieregistreringsdatum

Först inskickad

27 november 2012

Först inskickad som uppfyllde QC-kriterierna

27 november 2012

Första postat (Uppskatta)

29 november 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

21 december 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2016

Senast verifierad

1 december 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CARMA

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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Platser

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