Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients

Vascular Access Complication Clinical Trial

— CRVADHPNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948514
• Other study ID #: 69HCL22_1128
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Vascular Access Complication
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud-Hospices Civils de Lyon	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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