Clinical trial NCT03855969: Central Venous Access Device Removal in Cancer Patients
Official title: Frequency of Central Venous Port Catheter Removal Due to Suspected Infection in Patients Diagnosed With Cancer at a Single Institution: A Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Haematological Malignancy
Keywords: PAC infections
oncology
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 1402
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Suspected infection rate
timeFrame: 2012-2017
Secondary outcomes:
measure: Approved infection rate
timeFrame: 2012-2017
measure: Risk factors for central venous access device infections in cancer patients
timeFrame: 2012-2017
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: GHGroeninge
Study officials:
References: