Central Venous Access Device Removal in Cancer Patients

Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.

Background:

Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.

The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.

Trial objectives:

The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.

The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.

At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.

Study Overview

• Status: Completed
• Conditions: Oncology; Haematological Malignancy
• Intervention / Treatment: Procedure: Removal of a central venous access device

• Study Type: Observational
• Enrollment (Actual): 1402

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium
    • GHGroeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We are interested in cancer patients who were implanted a central venous access device with regard to their cancer treatment, but for which the device was removed.

Description

Inclusion Criteria:

• Central venous access device removal in our general hospital
• Cancer patient

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suspected infection rate	How many central venous access devices are removed due to a suspected infection of the device in cancer patients.	2012-2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Approved infection rate	For how many of the central venous access devices that were removed due to suspected infection of the device could an infection be confirmed?	2012-2017
Risk factors for central venous access device infections in cancer patients	Is it possible to denote certain variables as potential risk factors for central venous access device infection?	2012-2017

Collaborators and Investigators

• Sponsor: General Hospital Groeninge

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: oncology; PAC infections
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: AZGS2018106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publically and shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No