Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients

NCT05948514 | Completed

• 1 other identifier: 69HCL22_1128
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access device

  * 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

  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

Study Arms (1)

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

Interventions

The complications related to central venous access device OTHER

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.

adult patients followed up in the nutrition and access device was inserted for parenteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients receiving HPN

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud-Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 17, 2023
• Study Start: July 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

FR (1)