Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients

Completed

• Conditions: Vascular Access Complication
• Interventions: Other: The complications related to central venous access device

• Registration Number: NCT05948514
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients followed up in the nutrition and access device was inserted for parenteral nutrition	The complications related to central venous access device	no intervention, observational study patients are enrolled, and followed up until a catheter related complication occurs

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud-Hospices Civils de Lyon; 🇫🇷 Pierre Bénite, France