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Trial registered on ANZCTR


Registration number
ACTRN12616000950460
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
19/07/2016
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Date results information initially provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patterns of artificial kidney failure during continuous renal replacement therapy
Scientific title
Patterns of artificial kidney failure during continuous renal replacement therapy
Secondary ID [1] 289587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney injury 299349 0
Condition category
Condition code
Renal and Urogenital 299330 299330 0 0
Other renal and urogenital disorders
Renal and Urogenital 299357 299357 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
7
Target follow-up type
Weeks
Description of intervention(s) / exposure
To perform an analysis of continuous renal replacement therapy filter and circuit pressures that are monitored and recorded throughout the entire dialysis treatment period in order to determine the patterns of change associated with artificial kidney failure. Patient's will be followed through their intensive care unit admission in order to obtain continuous renal replacement therapy utilization through to hospital discharge.
Intervention code [1] 295191 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298806 0
Data on continuous renal replacement therapy filter and circuit pressure changes during treatment interventions will be downloaded from the dialysis machine. The data downloaded will then analysed to identify changes in each patient over time.
Timepoint [1] 298806 0
At the end of each continuous renal replacement therapy treatment.
Primary outcome [2] 298826 0
Hours of artificial filter life
Timepoint [2] 298826 0
At the end of each continuous renal replacement therapy treatment via a medical record audit.
Secondary outcome [1] 325257 0
Access pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.
Timepoint [1] 325257 0
Continuous monitoring from commencement to end of continuous renal replacement therapy..
Secondary outcome [2] 325316 0
Filter pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.
Timepoint [2] 325316 0
Continuous monitoring from commencement to end of continuous renal replacement therapy..
Secondary outcome [3] 325317 0
Return pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.
Timepoint [3] 325317 0
Continuous monitoring from commencement to end of continuous renal replacement therapy..
Secondary outcome [4] 325318 0
Effluent pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.
Timepoint [4] 325318 0
Continuous monitoring from commencement to end of continuous renal replacement therapy..
Secondary outcome [5] 325319 0
Replacement pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.
Timepoint [5] 325319 0
Continuous monitoring from commencement to end of continuous renal replacement therapy..

Eligibility
Key inclusion criteria
Adult critically ill patients who are receiving continuous renal replacement therapy as determined by their treating intensive care unit physician.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those aged less than 18 years, not admited to an intensive care unit and who do not receive renal replacement therapy as a part of their care during their admission to the intensive care unit.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
All statistical analysis will be performed using SPSS version 19.0 (SPSS, Chicago, IL). We will perform descriptive and frequency statistical procedures. The statistical analysis will also include baseline comparisons using Chi-square tests for equal proportion with results reported as numbers, percentages (%), and 95% confidence intervals (CI).

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)
VIC
Recruitment hospital [1] 6067 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 13515 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 293975 0
Other Collaborative groups
Name [1] 293975 0
Anaesthesia Intensive Care Trust Fund (Austin Hospital)
Address [1] 293975 0
c/o Professor Rinaldo Bellomo
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084
Country [1] 293975 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 292789 0
Individual
Name [1] 292789 0
Professor Rinaldo Bellomo
Address [1] 292789 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084
Country [1] 292789 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295391 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 295391 0
145 Studley Road
Heidelberg
Victoria, 3084
Ethics committee country [1] 295391 0
Australia
Date submitted for ethics approval [1] 295391 0
11/11/2014
Approval date [1] 295391 0
26/11/2014
Ethics approval number [1] 295391 0
LNR/14/Austin/596

Summary
Brief summary
During continuous renal replacement therapy (CRRT), blood is passed through a multi-lumen extracorporeal circuit that includes access, filter, return, effluent and replacement/dialysate components. Although anticoagulants, such as heparin and citrate, are commonly used, clotting of extracorporeal circuit and filter commonly occurs leading to shortened therapy duration or a failure to delivery therapy. In addition, inadequate treatment leads to circuit loss (including increased blood loss), increased costs (of circuits) and a loss of nursing time. The relationship between circuit pressures and artificial kidney failure in CRRT remains unclear.

In response, we wish to perform an analysis of CRRT filter and circuit pressures in order to determine the patterns of change associated with artificial kidney failure. Specifically, we wish to evaluate the relative contribution of access circuit, filter, effluent, return circuit and trans-membrane (across the filter) pressures on the lifespan of the artificial kidney. In this pilot investigation we feel that 100 CRRT circuits will provide sufficient quantity of data to aid in the description of patterns of circuit pressure changes occurring during CRRT. Significantly, the findings of this study would provide insight into the dynamic changes of circuit pressures during CRRT, and defined the patterns of artificial kidney failure in CRRT. Such information will inform future prospective investigations aimed at improving the care of critically ill patients requiring CRRT. We plan to publish the audit findings in peer-reviewed critical care or artificial kidney injury journals. Participant anonymity and confidentiality will be preserved as only aggregated findings will be presented or reported.
Trial website
Trial related presentations / publications
Zhang L, Tanaka A, Zhu G, Baldwin I, Eastwood GM, Bellomo R. Patterns and Mechanisms of Artificial Kidney Failure during Continuous Renal Replacement Therapy. Blood Purif 2016:41:254-263.
Public notes

Contacts
Principal investigator
Name 67094 0
Prof Rinaldo Bellomo
Address 67094 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 67094 0
Australia
Phone 67094 0
+61 3 9496 5992
Fax 67094 0
+61 3 9496 3932
Email 67094 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 67095 0
A/Prof Glenn Eastwood
Address 67095 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 67095 0
Australia
Phone 67095 0
+61 3 9496 4835
Fax 67095 0
+61 3 9496 3932
Email 67095 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 67096 0
Prof Rinaldo Bellomo
Address 67096 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 67096 0
Australia
Phone 67096 0
+61 3 9496 5992
Fax 67096 0
+61 3 9496 3932
Email 67096 0
rinaldo.bellomo@austin.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
Policy on data sharing not finalised.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
We aimed to describe the previously unstudied relationship between circuit pressures and circuit clotting, here labeled as ‘artificial kidney failure’ (AKF), in patients receiving continuous renal replacement therapy. To answer this we performed an observational study of CRRT-treated critically ill patients to continuously record the multiple CRRT circuit pressures. Results: Three patterns of access outflow dysfunction (AOD) were also noted: severe, moderate and mild. Compared with circuits without AOD, circuits experiencing at least one AOD episode had shorter lifespans (14.2 ± 12.7 vs. 21.3 ± 16.5 h, p = 0.057). This effect was more obvious with moderate or severe AOD (8.7 ± 4.6 vs. 20.6 ± 15.7 h, p = 0.007). If any AOD events occurred within the first 4 h, the sensitivity and specificity in predicting early-immediate AKF were 53.4 and 94.4%, respectively. In summary, early and intermediate AKF during CRRT is
most likely dependent on AOD, which is a frequent event with variable severity.