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Trial registered on ANZCTR
Registration number
ACTRN12613000300774
Ethics application status
Approved
Date submitted
23/02/2013
Date registered
19/03/2013
Date last updated
19/03/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of supported guideline implementation in a network of renal units on rates of infection in their peritoneal dialysis patients
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Scientific title
The effect of supported clinical practice guideline implementation in a network of renal units on rates of infection and time to first infection in their peritoneal dialysis patients
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Secondary ID [1]
282015
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nil
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Universal Trial Number (UTN)
U1111-1139-7864
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Trial acronym
nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clinical practice variation
288457
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Effect of active guideline implementation
288458
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Prevention of peritoneal dialysis-related infection
288459
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Identify barriers and enablers to guideline implementation
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Kidney disease
288646
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Condition category
Condition code
Infection
288805
288805
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0
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Other infectious diseases
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Public Health
288984
288984
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0
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Health service research
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Renal and Urogenital
288985
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention: Active implementation of 3 evidence-based guideline recommendations. *Guideline recommendation #1: Intravenous antibiotic prophylaxis prior to peritoneal dialysis catheter insertion should be used to reduce the risk of early peritonitis (Level I evidence) (either Vancomycin, Cephalosporin or Gentamicin can be used)
How it will be implemented: A clinical pathway will be developed with surgical team input to include IV antibiotic administration pre-operatively by a designated individual. A 1-page checklist will also be developed.
*Guideline recommendation #2: Prophylactic therapy using mupirocin ointment, especially for Staphylococcus aureus carriage (intranasally or at exit site) is recommended to decrease the risk of Staphylococcus aureus catheter exit site/tunnel infections and peritonitis (Level I evidence).
How it will be implemented: Units can choose 1 of 2 options:
1) Unit protocol to include nasal swabbing of each PD patient every 6 months by a nurse, with treatment (nasal mupirocin) prescribed on the return of a positive swab for S. aureus or MRSA. Patient and staff education to explain that this should occur.
2) Unit protocol to include daily application of mupirocin to catheter exit site by patient/carer or nurse. Patient, GP and staff education to explain that this is the agreed procedure.
A 1-page checklist will also be developed for both options.
*Guideline recommendation #3: The use of oral antifungal prophylaxis should be considered at the time of antibiotic administration to peritoneal dialysis patients to reduce the occurrence of fungal peritonitis (Level II evidence).
How it will be implemented: Unit protocol to include prescribing of nystatin (Nilstat) whenever PD patients are prescribed antibiotics. Patient, GP and staff education to explain that this should occur. Patients will also be given a wallet size card containing the relevant information. A letter to their GP will be sent by the unit nurse for all new PD patients, outlining the need for anti-fungal prescribing. A 1-page checklist will be developed for use when PD patients come to hospital.
Duration: A 6 month baseline period has been completed. A 12 month implementation period will start approx. April 2013.
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Intervention code [1]
286589
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Prevention
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Comparator / control treatment
Baseline infection and morbidity/mortality data collected from participating hospitals over the 6 month baseline period (12 Dec 2011 - 30 June 2012).
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Control group
Historical
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Outcomes
Primary outcome [1]
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Primary Outcome 1: To establish current practice and protocols at 8 units in relation to key guideline recommendations for the prevention of infection in PD patients.
A process map has been made for each unit after interviewing nurse staff members. Further detail has been obtained from the nephrologist in response to a questionnaire.
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Assessment method [1]
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Timepoint [1]
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Timepoint: Baseline monitoring period of 6 months (12 Dec 2011 – 30 June 2012).
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Primary outcome [2]
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Primary Outcome 2: Rates of and time to first exit site/tunnel-associated infection and/or peritonitis among new PD patients and technique survival rates after active implementation of key guideline recommendations.
A case report form (CRF) has been developed to record key information about each patient and any infection episodes or technique failures that occur. Each unit will be asked to complete a CRF at the end of each month for any patient who experiences an infection or technique failure in that month. The completed forms will be sent to the Project Officer for the study, and the details entered into the study database. The infection outcomes will be defined according to internationally accepted criteria.
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Assessment method [2]
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Timepoint [2]
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Timepoint: 12 months after intervention commencement.
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Primary outcome [3]
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Primary Outcome 3: Identification of barriers and enablers to implementation of key guidelines related to prevention of infection in PD patients in 8 ANZ renal units.
After visiting each unit and making their process map and obtaining replies to questions about unit practice, protocols and policies, a table was created by the Project Officer which lists perceived barriers and enablers at the patient, physician and organisation levels. These were sent to each unit for their feedback. The NICS Barrier Tool was used for this.
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Assessment method [3]
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Timepoint [3]
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Timepoint: Baseline and 12 months after intervention commencement.
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Secondary outcome [1]
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Secondary Outcome 1: Quality of Life of patients who experience any of the 3 types of PD-related infection as assessed by 2 questionnaires (KDQOL-36; EuroQol-5d-5l).
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Assessment method [1]
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Timepoint [1]
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Timepoint: At start of PD, after 6 months of PD, after 12 months of PD, for those who do not experience any PD-related infection. At 2 weeks (post infection), 1 month, 3 months, 6 months, 9 months, 12 months for those who do experience a PD-related infection.
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Eligibility
Key inclusion criteria
Include all new patients who have had a Tenckhoff catheter inserted (but not yet dialysing) and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include all new patients undergoing peritoneal dialysis in your unit who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include all new patients who have had a Tenckhoff catheter re-inserted or who have had surgery because of catheter movement and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include private patients who are included under your unit's ANZDATA returns.
Include returning transplant patients.
Include patients who have transferred from haemodialysis.
Only include patients who are on the chronic dialysis program.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Acute renal failure patients who recover.
Patients who have had a Tenckhoff catheter inserted prior to the trial start date and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Patients undergoing peritoneal dialysis in your unit who commenced dialysis prior to the trial start date and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a before/after study. The baseline period acts as the control period. In the intervention phase, all patients at the participating units who meet the inclusion criteria will be given the intervention.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A patient data collection form and Access database have been developed to collect and store patient data. Analyses will be by comparative statistics examining outcomes before and after the implementation phase. Measures will largely consist of binary outcomes. Univariate associations for clinical variables among the 8 renal units will be explored using analysis of variance for continuous variables and Chi-2 test or Fisher exact test for categorical variables, where appropriate.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2013
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Actual
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Date of last participant enrolment
Anticipated
31/03/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
270
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
660
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
661
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [3]
662
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Gosford Hospital - Gosford
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Recruitment hospital [4]
663
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Westmead Hospital - Westmead
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Recruitment hospital [5]
664
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Sunshine Hospital - St Albans
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Recruitment hospital [6]
665
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [7]
666
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Royal Hobart Hospital - Hobart
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Recruitment postcode(s) [1]
6397
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
6398
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4029 - Royal Brisbane Hospital
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Recruitment postcode(s) [3]
6399
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2250 - Gosford
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Recruitment postcode(s) [4]
6400
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2145 - Westmead
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Recruitment postcode(s) [5]
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3021 - St Albans
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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7008 - New Town
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
4882
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Auckland
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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KHA-CARI Guidelines
Kidney Health Australia
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Address [1]
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Centre for Kidney Research
Locked Bag 4001
Westmead NSW 2145
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Assoc Prof David Mudge
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Address
Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Martin Gallagher
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Address [1]
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Renal Office, 3 West
Concord Hospital, Hospital Road
Concord NSW 2137
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Country [1]
285577
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Australia
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Secondary sponsor category [2]
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Individual
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Name [2]
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Prof Jonathan Craig
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Address [2]
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Centre for Kidney Research, Locked Bag 4001, Westmead NSW 2145.
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Country [2]
285578
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Australia
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Secondary sponsor category [3]
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Individual
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Name [3]
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Dr Dwarakanathan Ranganathan
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Address [3]
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Dept of Nephrology,
Royal Brisbane & Women’s Hospital
Cnr Butterfield St and Bowen Bridge Rd
Herston QLD 4029
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Country [3]
285579
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Australia
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Secondary sponsor category [4]
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Individual
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Name [4]
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Dr Wai Hon Lim
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Address [4]
285580
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Dept of Renal Medicine,
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
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Country [4]
285580
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Australia
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Secondary sponsor category [5]
285581
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Individual
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Name [5]
285581
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Dr Walaa Saweirs
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Address [5]
285581
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Renal Unit,
Whangarei Hospital
Private Bag 9742
Whangarei NZ 0148
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Country [5]
285581
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New Zealand
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Secondary sponsor category [6]
285702
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Individual
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Name [6]
285702
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Dr David Andresen
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Address [6]
285702
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Dept of HIV, Infectious Diseases and Immunology
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
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Country [6]
285702
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Australia
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Secondary sponsor category [7]
285703
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Individual
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Name [7]
285703
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Dr Michelle Irving
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Address [7]
285703
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Centre for Kidney Research
Locked Bag 4001
Westmead Children's Hospital
Westmead NSW 2145
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Country [7]
285703
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
277296
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Prof David Johnson
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Address [1]
277296
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Director of Nephrology
ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country [1]
277296
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Australia
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Other collaborator category [2]
277297
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Individual
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Name [2]
277297
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Dr Nigel Toussaint
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Address [2]
277297
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Physician in Charge
Home Dialysis Therapies
Western Hospital
Gordon Street
Footscray VIC 3011
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Country [2]
277297
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Dr Fiona Brown
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Address [3]
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Dept of Nephrology
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
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Country [3]
277299
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Australia
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Other collaborator category [4]
277300
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Individual
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Name [4]
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Dr Karthik Kumar
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Address [4]
277300
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Gosford Nephrology
G/F, 37 William Street
Gosford NSW 2250
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Country [4]
277300
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Australia
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Other collaborator category [5]
277301
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Individual
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Name [5]
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Assoc Prof Kamal Sud
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Address [5]
277301
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Head, Dept of Renal Medicine (Nepean Hospital)
Co-Director, PD Unit (SWAHS)
PO Box 63
Nepean Hospital
Kingswood NSW 2750
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Country [5]
277301
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Australia
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Other collaborator category [6]
277302
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Individual
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Name [6]
277302
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Dr Geoffrey Kirkland
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Address [6]
277302
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Dept of Nephrology
Royal Hobart Hospital
GPO Box 1061
Hobart TAS 7001
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Country [6]
277302
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Australia
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Other collaborator category [7]
277303
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Individual
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Name [7]
277303
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Dr Maha Yehia
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Address [7]
277303
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Dept of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
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Country [7]
277303
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288857
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Service Improvement Unit - CHW
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Ethics committee address [1]
288857
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Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
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Ethics committee country [1]
288857
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Australia
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Date submitted for ethics approval [1]
288857
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Approval date [1]
288857
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01/07/2011
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Ethics approval number [1]
288857
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QIE-2011-06-02
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Ethics committee name [2]
288858
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HREC University of Sydney
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Ethics committee address [2]
288858
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Level 6
Jane Foss Russell Building - G02
The University of Sydney
Camperdown NSW 2006
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Ethics committee country [2]
288858
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Australia
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Date submitted for ethics approval [2]
288858
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Approval date [2]
288858
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31/08/2011
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Ethics approval number [2]
288858
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Protocol No. 14086
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Summary
Brief summary
The primary purpose of the study is to see if assisting 8 renal units to actively put certain clinical practice guideline recommendations into practice will result in fewer infections and a longer time to first infection in their peritoneal dialysis patients. The study hypothesis is that assisting nephrologists and renal nurses to follow infection prevention guidelines in their daily practice will lead to better patient outcomes in terms of less PD-related infections, better quality of life, less need to remove Tenckhoff catheters and less technique failure (and transfer to haemodialysis or withdrawal from dialysis altogether).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof David Mudge
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Address
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Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country
38090
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Australia
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Phone
38090
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+61 7 3176-7765
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Fax
38090
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+61 7 3176-5480
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Email
38090
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[email protected]
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Contact person for public queries
Name
38091
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Ms Denise Campbell
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Address
38091
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Centre for Kidney Research
Locked Bag 4001
Westmead NSW 2145
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Country
38091
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Australia
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Phone
38091
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+61 2 9845 1477
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Fax
38091
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+61 2 9845 1491
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Email
38091
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[email protected]
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Contact person for scientific queries
Name
38092
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A/Prof David Mudge
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Address
38092
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Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
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Country
38092
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Australia
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Phone
38092
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+61 7 3176-7765
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Fax
38092
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+61 7 3176-5480
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Email
38092
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[email protected]
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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.
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