Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001193965
Ethics application status
Approved
Date submitted
13/09/2011
Date registered
17/11/2011
Date last updated
18/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Needleless Connectors in Dialysis
Scientific title
A quality assurance project evaluating patient experience, staff experience and incidence of catheter related blood stream infections in two methods of needleless connections for haemodialysis
Secondary ID [1] 263000 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis patients 270732 0
Condition category
Condition code
Renal and Urogenital 270908 270908 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who need temporary access for haemodialysis have a permcath inserted. When connecting the blood lines to the permcath for haemodialysis treatment 2 different methods can be used:
1. Open procedure:
2. Needleless connector procedure:
This is a quality assurance project evaluating two methods of needleless connections for haemodialysis.
Each procedure will be used for one month, then cross-over to the other method (A washout period is not possible as a patient needs constant treatment so connection by one or other method will always be required).
1. Open procedure: set up of a sterile field to connect the blood lines to the permcath.
2. Needleless procedure: use a a device called a BD Q-Syte to connect the blood lines to the permcath.
Intervention code [1] 269348 0
Treatment: Devices
Comparator / control treatment
This is a cross -over study: patients will be randomised to either open procedure or needleless connector procedure and after one month cross over to the other procedure. Until recently the open procedure was more commonly used, however the hospital New Technology/Procedure Committee has now approved the use of BD Q-Syte so it is anticipated this will now become more common.
Control group
Active

Outcomes
Primary outcome [1] 279614 0
Improved patient experience with reduced connection/disconnection times. A Likert scale will be used to assess patient satisfaction.
Timepoint [1] 279614 0
After two months
Primary outcome [2] 279615 0
Improved staff experience with reduced connection/disconnection times. A Likert scale will be used to assess staff satisfaction.
Timepoint [2] 279615 0
After two months
Primary outcome [3] 279616 0
No difference in Catheter Related Blood Stream Infections (CR BSI). Microbiology and pathology results from patients medical notes will be recorded.
Timepoint [3] 279616 0
After two months
Secondary outcome [1] 294877 0
Nil
Timepoint [1] 294877 0
Nil

Eligibility
Key inclusion criteria
Patient has a permcath in situ being used for haemodialysis (or other renal treatment such as plasmaphoresis)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent.
Patient has a current, active infection.
Permcath not expected to be in situ for longer than 1 month.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After signing the consent form each patient will be allocated a study number. Patients will be randomly allocated to either the ‘open procedure’ or the ‘needleless connector procedure’. After one month, the patients will cross-over to the alternate procedure. Allocation to the starting group will be concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random list of numbers will generated from the website: random.org/lists
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
7/03/2012
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269839 0
Self funded/Unfunded
Name [1] 269839 0
Country [1] 269839 0
Australia
Primary sponsor type
Other
Name
Eastern Health Integrated Renal Service
Address
Level 2, 5 Arnold Street
Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 268870 0
None
Name [1] 268870 0
Address [1] 268870 0
Country [1] 268870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271812 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 271812 0
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Ethics committee country [1] 271812 0
Australia
Date submitted for ethics approval [1] 271812 0
28/09/2011
Approval date [1] 271812 0
05/12/2011
Ethics approval number [1] 271812 0
LR32/1112

Summary
Brief summary
A quality assurance project to assess the two different methods of connecting blood lines to permcaths for haemodialysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33127 0
Ms Jennifer Howard
Address 33127 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 33127 0
Australia
Phone 33127 0
+61 3 9091 8872
Fax 33127 0
Email 33127 0
[email protected]
Contact person for public queries
Name 16374 0
Ms Jennifer Howard
Address 16374 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 16374 0
Australia
Phone 16374 0
+61 3 9091 8872
Fax 16374 0
Email 16374 0
[email protected]
Contact person for scientific queries
Name 7302 0
Ms Jennifer Howard
Address 7302 0
Eastern Health Integrated Renal Service
Level 2, 5 Arnold Street, Box Hill, Victoria, 3128
Country 7302 0
Australia
Phone 7302 0
+61 3 9091 8872
Fax 7302 0
Email 7302 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
No additional documents have been identified.