Central Venous Access Device Removal in Cancer Patients

NCT03855969 | Completed

• 1 other identifier: AZGS2018106
• Study Type: observational
• Target: 1,402
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Haematological Malignancy

Keywords

PAC infections; oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Approved infection rate

  2012-2017

• Risk factors for central venous access device infections in cancer patients

  2012-2017

Interventions

Removal of a central venous access device PROCEDURE

We are interested in those patients for which a central venous access device was removed.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• General Hospital Groeninge: lead

Study Sites (1)

GHGroeninge

Kortrijk, Belgium

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: March 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)