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Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients (CRVADHPNP)

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ClinicalTrials.gov Identifier: NCT05948514
Recruitment Status : Completed
First Posted : July 17, 2023
Last Update Posted : July 17, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Vascular Access Complication Other: The complications related to central venous access device

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Venous Thromboembolism and Infections Associated With Three Vascular Access Devices in Home Parenteral Nutrition : a Prospective Cohort Study
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : December 30, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
adult patients followed up in the nutrition and access device was inserted for parenteral nutrition
no intervention, observational study patients are enrolled, and followed up until a catheter related complication occurs
 Other: The 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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access device [ Time Frame: From 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients receiving HPN
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948514


Locations
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France
Centre Hospitalier Lyon Sud-Hospices Civils de Lyon
Pierre Bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05948514    
Other Study ID Numbers: 69HCL22_1128
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: July 17, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
central venous access device
catheter-related complications
venous thromboembolism
 catheter-related bloodstream infection
peripherally inserted central catheters
home parenteral nutrition
Additional relevant MeSH terms:
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Venous Thromboembolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases