Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000738527
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
17/07/2015
Date last updated
20/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Replacing peripheral intravenous catheters: an observational study of peripheral intravenous catheter outcomes in adult hospitalised patients
Scientific title
Complication of peripheral intravenous catheters - a prospective observational study
Secondary ID [1] 287018 0
Nil
Universal Trial Number (UTN)
Trial acronym
REPLACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter failure 295485 0
Condition category
Condition code
Public Health 295740 295740 0 0
Health service research

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 medical, surgical and maternity services, within the preceding 24 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 other risk factors collected: e.g. antibiotic type and dosage, flushing regime, continuous or intermittent intravenous fluid administration, dressing and other securement types of both catheter and tubing, presence of extension tubing or 3-way taps, catheter type and size, patient factors such as mobility status, presence of delirium. Participants will be monitored until discharge from hospital or until they have a central venous access device inserted.
Intervention code [1] 292225 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295457 0
Peripheral intravenous catheter (PIVC) failure will be considered to have occurred if the catheter was an unplanned removal from any cause (includes infiltration, blockage, phlebitis, accidental removal or suspected infection). This information will be collected by the research nurse on second daily review from either direct observation, consultation with the clinical staff or review of medical record.
Timepoint [1] 295457 0
Monitored on a second daily basis during hospital admission or until insertion of a CVL.
Secondary outcome [1] 315607 0
Cost of catheter replacement
Timepoint [1] 315607 0
This will be collected at the completion of study from information in our existing data set
Secondary outcome [2] 315608 0
Length of hospital stay
Timepoint [2] 315608 0
Date of discharge will coincide with date of discharge from study and be collected prospectively by research nurse, unless the patient has a CVL inserted, in which case this data will be collected retrospectively from medical records at study completion.
Secondary outcome [3] 315609 0
Type of bacteria colonising peripheral catheters or on the skin will be collected from hospital records as per current clinical practice. A sub-study of a random 10% of PIVC and skin swabs will be collected at catheter removal. The skin swabs will be streaked onto blood agar, and IVD segments roll-plated.
Timepoint [3] 315609 0
Type of bacteria colonising peripheral catheters will be collected by research nurse from medical records or the sub-study data set at the time of discharge or insertion of CVL.

Eligibility
Key inclusion criteria
1. Patients requiring peripheral intravenous catheters and able to provide informed consent
2. Catheter inserted within 24 hours of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients admitted for palliative treatment or who are on a care of the dying pathway
2. Patients who are under the age of 18 years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2014
Actual
15/10/2014
Date of last participant enrolment
Anticipated
18/12/2015
Actual
26/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3991 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 9897 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 291570 0
University
Name [1] 291570 0
Griffith Health Institute, Griffith University
Country [1] 291570 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan Qld 4111
Country
Australia
Secondary sponsor category [1] 290246 0
University
Name [1] 290246 0
NHMRC Centre of research Excellence in Nursing Interventions for Hospitalised Patients (NCREN), Griffith University
Address [1] 290246 0
Griffith University, Gold Coast campus, Southport, QLD 4222
Country [1] 290246 0
Australia
Secondary sponsor category [2] 290247 0
Commercial sector/Industry
Name [2] 290247 0
Becton, Dickinson and Company (BD)
Address [2] 290247 0
1 Becton Drive, Franklin Lakes, NJ 07417-1815
Country [2] 290247 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293110 0
Royal Brisbane and Women's Hospital, Human Reserach Ethics Committee
Ethics committee address [1] 293110 0
Ethics committee country [1] 293110 0
Australia
Date submitted for ethics approval [1] 293110 0
24/02/2014
Approval date [1] 293110 0
09/04/2014
Ethics approval number [1] 293110 0
HREC/14/QRBW/76
Ethics committee name [2] 293111 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 293111 0
Ethics committee country [2] 293111 0
Australia
Date submitted for ethics approval [2] 293111 0
24/04/2014
Approval date [2] 293111 0
28/04/2014
Ethics approval number [2] 293111 0
NRS/26/14/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58506 0
Prof Joan Webster
Address 58506 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 58506 0
Australia
Phone 58506 0
+61736468111
Fax 58506 0
Email 58506 0
[email protected]
Contact person for public queries
Name 58507 0
Nicole Marsh
Address 58507 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 58507 0
Australia
Phone 58507 0
+61736468740
Fax 58507 0
Email 58507 0
[email protected]
Contact person for scientific queries
Name 58508 0
Nicole Marsh
Address 58508 0
Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia
Country 58508 0
Australia
Phone 58508 0
+61736468740
Fax 58508 0
Email 58508 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProphylactic insertion of large bore peripheral intravenous catheters in maternity patients for postpartum haemorrhage: A cohort study.2018https://dx.doi.org/10.1111/ajo.12759
N.B. These documents automatically identified may not have been verified by the study sponsor.