Skip to content

Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients

Venous Thromboembolism and Infections Associated With Three Vascular Access Devices in Home Parenteral Nutrition : a Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05948514
Acronym
CRVADHPNP
Enrollment
300
Registered
2023-07-17
Start date
2017-07-01
Completion date
2020-12-30
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access Complication

Keywords

central venous access device, catheter-related complications, venous thromboembolism, catheter-related bloodstream infection, peripherally inserted central catheters, home parenteral nutrition

Brief summary

Central vascular access devices are required for home parenteral nutrition (HPN). There is few data available concerning their complications in adult HPN patients, and the potential link between venous thromboembolism and catheter infection is not well established. The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access: peripherally inserted central catheters; tunneled catheters and port-a-cath devices, in adults patients on HPN; describe the risk factors, and identify a potential link between venous thromboembolism and infection. More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal. Venous complication (identify by an ultrasound examination if deep vein thrombosis is suspected), infection related to catheter and mechanical complications will be analyzed. The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter.

Interventions

OTHERThe complications related to central venous access device

The complications related to central venous access device were collected when occurs : from time of catheter insertion, until first complication, or removal for another type of catheter, or until death.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients * having a catheter insertion during the study periode * at the unit of vascular access of Lyon Sud Hospital * for parenteral nutrition * from July 1st, 2017 to June 30, 2020

Exclusion criteria

* catheter inserted in intensive care unit * for other treatment (chemotherapy, antibiotic)

Design outcomes

Primary

MeasureTime frameDescription
Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access deviceFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months* Deep vein thrombosis of the upper extremity : suspected if symptomatic (swelling, local pain, edema) and confirmed by venous ultrasound and/or computed tomography * Catheter related bloodstream infection suspected if local inflammation and/or fever, and confirmed by blood sample and/or catheter culture * Mechanical complications (displacement, drop, kink) : described by nurses or patient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026