ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000438358

Ethics application status

Approved

Date submitted

23/03/2017

Date registered

27/03/2017

Date last updated

4/02/2020

Date data sharing statement initially provided

19/03/2019

Date results information initially provided

19/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Cancer Care: The risk factors of venous access failure.

Scientific title

Cancer Care: The risk factors of venous access failure. A prospective observational study of peripheral and central venous catheter outcomes among adult patients within a tertiary care setting.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

CARETaKER

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peripheral and central venous catheter failure

Cancer

Condition category

Condition code

Public Health

Health service research

Cancer

Any cancer

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients with a peripheral intravenous catheter admitted to cancer care services unit, within the preceding 48 hour period will be identified prospectively. Consenting patients will have demographic data collected: e.g. admitting diagnosis, co-morbidities, skin and vein condition, cannula insertion details. Participants will be reviewed by a research nurse second daily and collect other risk factors including (but not limited to): antibiotic use, type and dosage, flushing regime, continuous or intermittent intravenous fluid administration, dressing and other securement types, presence of extension tubing or 3-way taps, catheter type and size. Details will be collected for all peripheral venous catheters the patient receives , as well as any subsequent central venous catheters during their hospital admission. Participants will be monitored until discharge from hospital.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable - Observational study only

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Update All cause peripheral venous catheter (PVC) failure: A composite of infection (suspected or laboratory confirmed local or bloodstream infection), occlusion, infiltration, leakage, dislodgement (complete or partial), or phlebitis. This composite measure incorporates the multifocal path to the same endpoint; PVC failure.

Timepoint [1]

At the time of PVC removal.

Secondary outcome [1]

PVC dwell time: calculated time (in hours) from device insertion until removal

Timepoint [1]

At the time of PVC removal.

Secondary outcome [2]

Insertion of a Central Venous Access Device (CVAD)

Timepoint [2]

Second-daily assessment until time of patient discharge or death.

Secondary outcome [3]

CVAD Failure:
A composite measure of any reason for unplanned CVAD removal, including infection, occlusion, dislodgement and venous thrombosis.

Timepoint [3]

At the time of CVAD removal.

Secondary outcome [4]

Adverse events: any adverse event relating to the lack of appropriate, safe and effective intravenous access (including missed treatment and/or infiltration of vesicant agents).

Timepoint [4]

Second-daily assessment until time of patient discharge or death.

Secondary outcome [5]

Length of hospital stay

Timepoint [5]

Date of admission will be collected upon enrolment, and date of discharge or death will be collected upon the patient's removal from the study.

Eligibility

Key inclusion criteria

(1) Cancer Care Services inpatient
(2) Patient able to provide informed consent
(3) PVC inserted within 48hours of admission

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) Patients who are on a care of the dying pathway
(2) Non-English speaking background (NESB) without an available interpreter
(3) Previous enrolment in the study

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Continuous data will be presented as means (and standard deviations), medians (and inter-quartile ranges); and categorical, nominal data will be presented as rates and percentages. For the primary outcomes, patients who experience peripheral vascular catheter failure will be compared against those who did not. Preliminary analysis will be performed to identify associations between risk factors and outcomes using independent sample t-tests or Chi-square tests, results will be presented as crude odds ratios (OR) and 95% confidence intervals (CI) or mean differences (MD) with their 95% CI. Predictors significant at the 0.1 level will inform multivariable modelling. As part of the analysis, potentially confounding factors and multicollinearity will be assessed. Survival analysis will be used to evaluate time-to-event data (e.g. time to catheter failure).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2017

Actual

20/10/2017

Date of last participant enrolment

Anticipated

6/07/2018

Actual

13/02/2019

Date of last data collection

Anticipated

20/07/2018

Actual

2/03/2019

Sample size

Target

200

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Brisbane and Women's Hospital Foundation

Address [1]

Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Rd
Herston, QLD 4029

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Nathan Campus
170 Kessels Rd
Nathan, QLD 4111

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Rd
Herston, QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston, QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/01/2017

Approval date [1]

02/03/2017

Ethics approval number [1]

HREC/17/QRBW/7

Ethics committee name [2]

Griffith University Human Research Ethics Committee

Ethics committee address [2]

Office for Research
Bray Centre
Nathan Campus, Griffith University
Kessels Rd,
Nathan, QLD 4111

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

02/03/2017

Approval date [2]

14/03/2017

Ethics approval number [2]

2017/154

Summary

Brief summary

This observational study will evaluate causes of catheter failure in cancer care patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have been admitted to a cancer care service inpatient unit, and have had a peripheral venous catheter (PVC) inserted within 48 hours of admission.

Study details
All participants in this study will be reviewed by a research nurse second daily throughout their hospital admission. Information will be collected about risk factors, such as antibiotic use, flushing regime, dressing types and catheter types; and catheter related outcomes such as PVC failure, insertion of a Central Venous Access Device (CVAD), adverse events, and hospital length of stay.

Participants in the study who experience peripheral catheter failure will be compared against those who did not, to identify the risk factors associated with this failure and how this can be mitigated. Patients who go on to receive Central Venous Access Devices (CVADs) will also be compared to those who do not, in order to explore the decision-making processes that go into transitioning to long-term devices (as well as the outcomes of these decisions e.g. CVAD success or failure).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Emily Larsen

Address

Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006

Country

Australia

Phone

+61 7 3646 8725

Fax

[email protected]

Contact person for public queries

Name

Ms Emily Larsen

Address

Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006

Country

Australia

Phone

+61 7 3646 8725

Fax

[email protected]

Contact person for scientific queries

Name

Ms Emily Larsen

Address

Nursing and Midwifery Research Centre
Level 2, Building 34
Royal Brisbane and Women's Hospital
Butterfield Street and Bowen Bridge Road
Herston
QLD 4006

Country

Australia

Phone

+61 7 3646 8725

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As per Human Research Ethics Committee approval conditions, no individual participant data will be publically available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1668	Ethical approval					372191-(Uploaded-19-03-2019-16-56-44)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Inherent and modifiable risk factors for peripheral venous catheter failure during cancer treatment: a prospective cohort study.	2021	https://dx.doi.org/10.1007/s00520-020-05643-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically