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Trial registered on ANZCTR


Registration number
ACTRN12614000965606
Ethics application status
Approved
Date submitted
20/08/2014
Date registered
9/09/2014
Date last updated
24/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Pilot Randomised Control Trial to Compare Failure Rates between Peripherally Inserted Central Catheter (PICC) and Anti-infective Peripherally Inserted Central Catheter (PICC) lines in patients that receive Total Parenteral Nutrition (TPN)
Scientific title
A Feasibility Pilot Randomised Control Trial to Compare Failure Rates between Peripherally Inserted Central Catheter (PICC) and Anti-infective Peripherally Inserted Central Catheter (PICC) lines in patients that receive Total Parenteral Nutrition (TPN)
Secondary ID [1] 285186 0
Nil
Universal Trial Number (UTN)
Trial acronym
CvP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter failure in patients receiving total parenteral nutrition 292787 0
central vascular access devices 292801 0
Condition category
Condition code
Other 293086 293086 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms. PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines.
The frequency and duration of the intervention device is from catheter insertion (time zero), until catheter removal or as no longer needed or patient death or catheter failure. Catheter failure is a composite endpoint including any line complication resulting in removal or exchange of the line. Failure then may include failure as a result of infection (CLABSI), catheter blockage necessitating removal or exchange, catheter associated venous thromboembolism , catheter dislodgement, and phlebitis.


All participants recruited will be randomised to one of two arms:

* * group 1 (Anti-infective PICC) The Cook Spectrum'Registered Trademark' Minocycline+Rifampin Impregnated PICC
* group 2 (Standard PICC) The Cook 'Registered Trademark'PICC
Intervention code [1] 290062 0
Treatment: Devices
Comparator / control treatment
Third party, distant, internet – based block randomisation (ref) will be used to ensure randomisation and complete allocation concealment. All participants recruited will be randomised to one of two arms:

• group 1 (Anti-infective PICC) The Cook Spectrum® Minocycline+Rifampin Impregnated PICC
• group 2 (Standard PICC) The Cook® PICC


Group 1, is the anti-infective peripherally inserted central catheters (PICC) inserted into the veins in the arm.
Group 2, is the standard peripherally inserted central catheter is inserted into the veins in the arm (which is different to group 1 but the same as the intervention), and the difference to the intervention is that this catheter is not coated with anti-infective agents.

The frequency and duration of the intervention device is from catheter insertion (time zero), until catheter removal or as no longer needed or patient death or catheter failure. Catheter failure is a composite endpoint including any line complication resulting in removal or exchange of the line. Failure then may include failure as a result of infection (CLABSI), catheter blockage necessitating removal or exchange, catheter associated venous thromboembolism , catheter dislodgement, and phlebitis.
Control group
Active

Outcomes
Primary outcome [1] 292965 0
The primary aim of this study is to determine in patients who receive TPN if there is a difference in the failure rates of an anti-infective PICC line, and a standard PICC line. Catheter failure is a composite endpoint including any line complication resulting in removal or exchange of the line. Failure then may include failure as a result of infection (CLABSI), catheter blockage necessitating removal or exchange, catheter associated venous thromboembolism , catheter dislodgement, and phlebitis
Timepoint [1] 292965 0
From catheter insertion (time zero), until catheter removal or as no longer needed or patient death or 48hours after patient discharge
Secondary outcome [1] 310032 0
The difference in the economic costs between the anti-infective PICC and the standard PICC line. This will be assessed by hospital costs, nurse costs, medical consultant costs.
Timepoint [1] 310032 0
Time zero will be catheter insertion, time of event will be catheter failure, and censor time will be patient discharge, catheter removal as no longer needed or patient death

Eligibility
Key inclusion criteria
Patients would be included in this study if they:
* are English speaking, competent, and provide informed consent to participation;
* are aged 18 years and older;
* are haemodynamically stable;
* require TPN;
* are suitable for the insertion of a PICC line
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients would be excluded from the study if they:
* are unable to give consent or decline consent;
* are pregnant;
* are allergic to the anti-infective catheter or its components;
* have an existing identified CLABSI.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Third party, distant, internet – based block randomisation will be used to ensure randomisation and complete allocation concealment. All participants recruited will be randomised to one of two arms:

*group 1 (Anti-infective PICC) The Cook 'Registered Trademark'SpectrumMinocycline+Rifampin Impregnated PICC
*group 2 (Standard PICC) The Cook 'Registered Trademark' PICC

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Third party, distant, internet – based block randomisation will be used to ensure randomisation and complete allocation concealment.
An independent research assistant in the CNR not otherwise involved in the study will organise randomisation by concealment in sequential numbered sealed opaque envelopes. Allocation of a participant to a study group will be by selection of the next sequentially numbered envelope, which will contain the group to which the participant is randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis
Power analysis has not been performed as this study is pilot study to obtain preliminary results to inform a larger funded study. We aim to recruit 30 patients per group as recommended for pilot studies (Hertzog, 2011).
Data will be analysed using SPSS version 22 (IBM SPSS Inc., 2008, Chicago, IL; www.spss.com), Intention-to-treat analysis will be applied. Baseline characteristics of the continuous variables will be expressed as mean ± standard deviation or median and inter-quartile range, and categorical data will be expressed as percentages. Continuous variables will be compared using t-tests, whilst categorical variables will be compared using Pearson chi-square tests or Fischer’s exact tests. Kaplan Meier and Cox regression will be used to compare the failure rates of the anti-infective PICC, and the standard PICC. Time zero will be catheter insertion, time of event will be catheter failure, and censor time will be patient discharge, catheter removal as no longer needed or patient death or 48 hours after discharge (CLABSI Guidelines). Hazard ratios and 95% confidence intervals will be calculated.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2898 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 11736 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 8625 0
6000 - City Delivery Centre
Recruitment postcode(s) [2] 23818 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 289809 0
Self funded/Unfunded
Name [1] 289809 0
Address [1] 289809 0
Country [1] 289809 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
6 Verdun Street
Nedlands
WA
6000
Country
Australia
Secondary sponsor category [1] 288502 0
University
Name [1] 288502 0
Edith Cowan University
Address [1] 288502 0
School of Nursing & Midwifery, ECU, Joondalup Campus, Joondalup Drive
Joondalup
WA
6027
Country [1] 288502 0
Australia
Other collaborator category [1] 278103 0
Individual
Name [1] 278103 0
Prof Di Twigg
Edith Cowan University
Address [1] 278103 0
School of Nursing & Midwifery, ECU, Joondalup Campus, Joondalup Drive
Joondalup
WA
6027
Country [1] 278103 0
Australia
Other collaborator category [2] 278104 0
Individual
Name [2] 278104 0
Dr Staurt Baker
Address [2] 278104 0
Intensive Care Unit,
Level 4, G Block
Sir Charles Gairdner Hospital
6 Verdun Street
Nedlands
WA
6000
Country [2] 278104 0
Australia
Other collaborator category [3] 278105 0
Individual
Name [3] 278105 0
MS Linda Coventry
Address [3] 278105 0
Centre for Nursing Research
Level 1, Room 129, QQ Block,
QEII Medical Centre,
6 Verdun Street,
NEDLANDS
WA
6000
Country [3] 278105 0
Australia
Other collaborator category [4] 278106 0
Individual
Name [4] 278106 0
Mr Gavin Jackson
Address [4] 278106 0
Level 4, G Block
Sir Charles Gairdner Hospital
6 Verdun Street
Nedlands
WA
6000
Country [4] 278106 0
Australia
Other collaborator category [5] 278108 0
Individual
Name [5] 278108 0
Dr Matt Brbich
Address [5] 278108 0
Level 4, G Block
Sir Charles Gairdner Hospital
6 Verdun Street
Nedlands
WA
6000
Country [5] 278108 0
Australia
Other collaborator category [6] 278109 0
Individual
Name [6] 278109 0
Prof Claire Rickard
Address [6] 278109 0
NHMRC Centre of Research Excellence in Nursing Interventions
Griffith Health Institute Centre for Health Practice Innovation
116 Messines Ridge Road
Mr Gravatt
Brisbane
Queensland
4121
Country [6] 278109 0
Australia
Other collaborator category [7] 278110 0
Individual
Name [7] 278110 0
Mr Rob Palmer
Address [7] 278110 0
Sir Charles Gairdner Hospital
A Block Ground floor
6 Verdun Street
Nedlands
WA
6000
Country [7] 278110 0
Australia
Other collaborator category [8] 278111 0
Individual
Name [8] 278111 0
Ms Bobby Kemp
Address [8] 278111 0
Sir Charles Gairdner Hospital
A Block Ground floor
6 Verdun Street
Nedlands
WA
6000
Country [8] 278111 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291542 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 291542 0
6 Verdun Street
Nedlands
6000
Western Australia
Ethics committee country [1] 291542 0
Australia
Date submitted for ethics approval [1] 291542 0
26/08/2014
Approval date [1] 291542 0
20/02/2017
Ethics approval number [1] 291542 0
2016-270

Summary
Brief summary
This project will address a significant problem in healthcare which is to provide safe, effective and reliable vascular access when commencing a patient on Total Parenteral Nutrition (TPN). TPN is used in patients where the gastro-intestinal tract cannot be used for the ingestion, digestion and absorption of essential nutrition.

Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms.

PICCs can be associated with central line associated blood stream infection (CLABSI), thrombotic complications (thrombosis) and mechanical complications (catheter occlusion, phlebitis). These complications impact on the cost of care, and have the potential to be a life-threatening adverse event. To help combat this problem PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines.

There are few comparison studies that have analysed the safety and costs of the lines by comparing anti-infective PICCs and standard PICCs in patients that receive TPN. Despite this gap in research, there is an increased use of the PICC line based on perceived time benefit, lower cost and fewer mechanical complications, where there is a lack of scientific evidence to support this choice.
The main aim of this study is to determine if there is a difference in the failure rates and costs between the patients who receive TPN via an anti-infective PICC line and a standard PICC line.

This feasibility pilot study will be a carried out a single centre. Participants will be patients requiring the insertion of a CVAD for delivery of TPN during the study period that meet the inclusion criteria and sign consent.
They will be randomised into one of two groups, we aim to recruit 30 patients per group:

* group 1 (Anti-infective PICC)
* group 2 (Standard PICC)

It is envisaged that findings from this study will provide a foundation for a larger study to explore the failure rates of PICC and anti-infective PICC lines used for delivery of parenteral nutrition, and to develop recommendations for the choice of PICC in patients receiving TPN.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3041 3041 0 0

Contacts
Principal investigator
Name 50770 0
Dr Amanda Towell
Address 50770 0
Edith Cowan University
Joondalup Campus
Joondalup Drive
WA
6027
Country 50770 0
Australia
Phone 50770 0
+61 08 6304 3793
Fax 50770 0
Email 50770 0
a.towell@ecu.edu.au
Contact person for public queries
Name 50771 0
Dr Amanda Towell
Address 50771 0
Edith Cowan University
Joondalup Campus
Joondalup Drive
WA
6027
Country 50771 0
Australia
Phone 50771 0
+61 08 6304 3793
Fax 50771 0
Email 50771 0
a.towell@ecu.edu.au
Contact person for scientific queries
Name 50772 0
Ms Linda Coventry
Address 50772 0
Edith Cowan University
Joondalup Campus
Joondalup Drive
WA
6027
Country 50772 0
Australia
Phone 50772 0
+61 8 6151 0935
Fax 50772 0
Email 50772 0
Linda.coventry@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary