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Trial registered on ANZCTR


Registration number
ACTRN12616000830493
Ethics application status
Approved
Date submitted
17/06/2016
Date registered
23/06/2016
Date last updated
12/06/2019
Date data sharing statement initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
REDUcing the burden of dialysis Catheter ComplicaTIOns in patients with kidney disease: a National approach
Scientific title
REDUcing the burden of dialysis Catheter ComplicaTIOns in patients with kidney disease: a National approach

Secondary ID [1] 289484 0
None
Universal Trial Number (UTN)
NA
Trial acronym
REDUCCTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 299174 0
Haemodialysis Catheter complications 299175 0
Condition category
Condition code
Renal and Urogenital 299184 299184 0 0
Kidney disease
Infection 299215 299215 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped cluster wedge randomised implementation project
The Project will be carried out in 4 phases:
Phase I: Study site set up Dec 2015-Aug 2016
Phase II: Baseline data collection Dec 2016-ongoing
Phase III: Implementation (stepped wedge randomisation) April 2018-sept 2019
Phase IV: Post implementation data collection phase Sep 2019-Aug 2020

The individual components of the intervention are broken into three milestones in catheter use:
1. Interventions employed at the time of dialysis catheter insertion such as in operating theatres/radiology/renal units/ICU:
a. Ensuring hand hygiene at the time of catheter insertion
b. Use of full barrier protection at insertion
c. Cleansing of the insertion site with antiseptic solution
d. Avoidance of the femoral site for catheter insertion
e. Preference given to the use of subcutaneously tunnelled catheters
2. Interventions employed during the dialysis catheter maintenance phase by nursing staff on dialysis wards:
a. Use of a standardised catheter insertion site dressing technique using topical antimicrobial preparations (+/- intraluminal catheter locks/topical antimicrobial preparations) and standardised frequency of dressing change
b. Provision of standardised nurse-delivered training to patients and their caregivers on the importance of catheter care, along with provision of a patient information sheet on dialysis catheter care
c. Protocol driven training in the aseptic techniques for connection and disconnection of the catheter for each haemodialysis treatment
d. Training and provision of education materials to patients that enhance their skills in managing dialysis catheters
3. Interventions associated with dialysis catheter removal on dialysis wards by nursing and medical staff:
a. Ensure the timely removal of catheters when no longer required

The Interventions have now been finalised, but have not been broadly publicised. The final tranche of sites have implemented the interventions. We will be publishing the interventions in the next 6 months.
Intervention code [1] 295072 0
Treatment: Other
Comparator / control treatment
This is a stepped cluster wedge randomised implementation project. All sites in the study will function as a control group before they are randomized to receive the suite of interventions. All sites will receive the interventions as part of the implementation phase.
Participating Renal Units will continue their current processes of care around dialysis catheter insertion and management until they are randomised during the implementation phase. This will be governed by existing hospital policies and procedures.
Control group
Active

Outcomes
Primary outcome [1] 298670 0
Rate of dialysis catheter related bacteraemia.
The endpoint will be determined by review of routine hospital laboratory tests performed on the participants (blood, catheter tip, swab cultures)
Dialysis catheter related bacteraemia is defined as meeting one of the following criteria:
*Culture of the same organism from both the catheter tip and at least one percutaneous blood culture.
*Culture of the same organism from at least two blood samples (one from a catheter hub and the other from a peripheral vein or second lumen) meeting criteria for quantitative blood cultures or differential time to positivity.
*Bacteraemia in the absence of another source
*Rate unit is measured per 1000 catheter days.
Timepoint [1] 298670 0
Outcomes will be assessed 2 weeks post catheter line removal for each participant to enable all test results to be collected.
Secondary outcome [1] 324910 0
Suspected or probable catheter related bacteraemia defined as catheter removal for the reason of suspected infection with negative blood cultures
Timepoint [1] 324910 0
2 weeks post catheter removal
Secondary outcome [2] 324979 0
Determination of the burden of exposure to central venous dialysis catheters
The burden of exposure will be measured using line days and bacteraemia rates.
Dialysis catheter related bacteraemia is defined as meeting one of the following criteria:
*Culture of the same organism from both the catheter tip and at least one percutaneous blood culture.
*Culture of the same organism from at least two blood samples (one from a catheter hub and the other from a peripheral vein or second lumen) meeting criteria for quantitative blood cultures or differential time to positivity.
*Bacteraemia in the absence of another source
Timepoint [2] 324979 0
2 weeks post catheter removal
Secondary outcome [3] 324981 0
Determination of Economic burden that arises from dialysis catheter exposure and infection and the economic case for investing in the multi-faceted intervenions.
This will be determined through state-specific linkage to hospitalisation and death datasets and this aspect of the study will be finalised once the data linkage component is finalised.
Timepoint [3] 324981 0
Outcomes will be collected and assessed once data linkage is performed on state hospitalisation, mortality and morbidity data.
Data linkage is intended to be performed once at the end of the study.

Eligibility
Key inclusion criteria
All patients requiring a NEW central venous catheter for receipt of dialysis for:
*Initiation of maintenance haemodialysis
*Provision of acute haemodialysis for acute kidney injury (where the care of the dialysis catheter is under the auspices of the participating renal unit)
*Interim haemodialysis due to failure of an existing dialysis access (e.g.: failure of peritoneal dialysis, thrombosis of an existing arterio-venous fistula).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Data from any period where the care of catheter is under the auspices of a unit other than the renal unit

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)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The REDUCCTION Project will randomise the study intervention at the unit, rather than the patient, level. The suite of interventions will be rolled out in three successive tranches.

The timing of the implementation of the suite of interventions will be randomised at a unit level using a sequence generated by the Statistics Division, within The George Institute for Global Health (TGI). The Study staff at TGI will then communicate this to the primary contact person at the individual sites.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped Wedge Cluster Randomised trial. All units will be randomised to receive the intervention and the random factor is the timing of randomisation.
There will be 3 successive tranches of site randomisation over a 12 month period, whereby approximately 10 sites at each time-point will be allocated to the study intervention suite.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A formal statistical analysis plan will be derived for the study prior to analysis and publication of study results. The expected baseline rate of dialysis catheter related bacteraemia is 2.5 per 1000 catheter days, derived from Concord data and the published literature and the number of intervention points (n of steps) planned is 3. The powering is based upon the intervention resulting in a 50% reduction in the risk of catheter related bacteraemia. An additional consideration is the inter-cluster correlation co-efficient (ICC) which is conservatively estimated at 0.07 (this study design is robust to an increase in ICC), when the rate seen in a large US study from 2014 was 0.03. On the basis of these figures, the project has a power of over 0.9 to detect a 50% reduction in the bacteraemia rate using a proposed sample of 30 Renal units following 100 patients per ‘step’ in the stepped-wedge design. This is likely a conservative figure as the ICC in other studies has been substantially lower and the number of patients per step is likely to be more than 100 as the duration of follow up post intervention is longer for some units.

Recruitment
Recruitment status
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7967 0
New Zealand
State/province [1] 7967 0

Funding & Sponsors
Funding source category [1] 293848 0
Government body
Name [1] 293848 0
NHMRC
Address [1] 293848 0
Level 1 16 Marcus Clarke Street Canberra ACT 2601
Country [1] 293848 0
Australia
Funding source category [2] 293849 0
Other Collaborative groups
Name [2] 293849 0
ANZDATA Registry
Address [2] 293849 0
SAHMRI Building
Level 4 South
North Terrace
ADELAIDE
SOUTH AUSTRALIA 5001
Country [2] 293849 0
Australia
Funding source category [3] 293850 0
Government body
Name [3] 293850 0
Department of Health & Human Services, Victorian Government
Address [3] 293850 0
50 Lonsdale Street
Melbourne, Victoria, Australia 3000
Country [3] 293850 0
Australia
Funding source category [4] 293851 0
Charities/Societies/Foundations
Name [4] 293851 0
KHA-CARI Renal Guidelines
Address [4] 293851 0
KHA-CARI Guidelines Office
Centre for Kidney Research
Kids Research Institute
Children's Hospital at Westmead
Hawkesbury Rd
Westmead NSW 2045
Country [4] 293851 0
Australia
Funding source category [5] 293854 0
Other Collaborative groups
Name [5] 293854 0
Kidney Health Australia
Address [5] 293854 0
Level 9, 9–13 Young Street, Sydney NSW 2000
GPO Box 9993, Sydney NSW 2001
Country [5] 293854 0
Australia
Funding source category [6] 293855 0
Government body
Name [6] 293855 0
Sunshine Coast Hospital and Health Service
Address [6] 293855 0
Nambour General Hospital
Hospital Road
PO Box 547
Nambour QLD 4560
Country [6] 293855 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global health
Address
Renal and Metabolic Division,
Level 10, KGV
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 292686 0
None
Name [1] 292686 0
NA
Address [1] 292686 0
NA
Country [1] 292686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295276 0
Sydney Local Health District Human Research Ethics Committee – CRGH
Ethics committee address [1] 295276 0
Concord Repatriation General Hospital
Hospital Road,
Concord
NSW 2134
Ethics committee country [1] 295276 0
Australia
Date submitted for ethics approval [1] 295276 0
24/03/2016
Approval date [1] 295276 0
09/06/2016
Ethics approval number [1] 295276 0
HREC/16/CRGH/76

Summary
Brief summary
Healthcare associated infections (HAI) threaten the safety of patients and cause significant and life-threatening harm to patients and bring major additional costs to already stretched health budgets. Patients with kidney disease are especially susceptible to HAI, and most prominent among these is the harm associated with central venous haemodialysis catheter use. The absence of a systematic approach to the challenges arising from dialysis catheter use means one of the major patient safety challenges in this susceptible patient group remains very real, poorly measured and the subject of large variations in practice.

The REDUCCTION Project Objectives:
1. To define the clinical and economic burden of dialysis catheter exposure and bacteraemia across Australia and New Zealand at a facility level
2. To reduce dialysis catheter related bacteraemia through implementation of an evidence-based and systematic intervention package
3. To establish a framework from the evidence implementation project for monitoring dialysis catheter related bacteraemia and sustaining improvements from the intervention phase
Trial website
www.reducction.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66742 0
A/Prof Martin Gallagher
Address 66742 0
The George Institute for Global Health,
PO BOX M201
Missenden Road,
Camperdown NSW 2050
Country 66742 0
Australia
Phone 66742 0
+61299934500
Fax 66742 0
+61299934504
Email 66742 0
mgallagher@georgeinstitute.org.au
Contact person for public queries
Name 66743 0
Dr Sradha Kotwal
Address 66743 0
The George Institute for Global Health,
PO BOX M201
Missenden Road,
Camperdown NSW 2050
Country 66743 0
Australia
Phone 66743 0
+61299934500
Fax 66743 0
+61299934504
Email 66743 0
skotwal@georgeinstitute.org.au
Contact person for scientific queries
Name 66744 0
Dr Sradha Kotwal
Address 66744 0
The George Institute for Global Health,
PO BOX M201
Missenden Road,
Camperdown NSW 2050
Country 66744 0
Australia
Phone 66744 0
+61299934500
Fax 66744 0
+61299934504
Email 66744 0
skotwal@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This decision has not been made yet. Our ethics aprovals may not allow data sharing.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Summary results
No Results