Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05948514
Other study ID # 69HCL22_1128
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT04136561 - Novel Strategy to Encourage Early Removal of Central Venous Catheters N/A
Active, not recruiting NCT04054128 - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients Phase 4
Completed NCT02297308 - A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications N/A
Completed NCT01446263 - RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial Phase 3
Recruiting NCT05132712 - Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial Early Phase 1
Completed NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes Phase 3
Completed NCT02200458 - Near-infrared Software Performance Study N/A
Recruiting NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study N/A
Recruiting NCT04077762 - Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH) N/A
Completed NCT05982366 - Feasibility and Safety of the Routine Distal Transradial Approach N/A
Completed NCT05101720 - Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL N/A
Terminated NCT03879824 - Radial Versus Femoral Secondary Access During TAVI N/A
Recruiting NCT05741866 - Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs) N/A
Completed NCT05093699 - Dual-plane Ultrasound Imaging During Vascular Access Procedures N/A
Recruiting NCT02449798 - Prospective Feasibility Trial of AccuCath 2.25" BC Placed in Difficult Access Patients in the Emergency Department N/A
Active, not recruiting NCT02808208 - Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure Phase 1/Phase 2
Completed NCT04409418 - Blood Sampling Functionality of Extended Dwell Catheters N/A
Recruiting NCT04472221 - Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access N/A
Completed NCT02558153 - RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula N/A
Completed NCT01927185 - Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation N/A