ANZCTR - Registration

Please note that the copy function is not enabled for this field.
If you wish to modify existing outcomes, please copy and paste the current outcome text into the Update field.

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616000950460

Ethics application status

Approved

Date submitted

1/07/2016

Date registered

19/07/2016

Date last updated

7/08/2020

Date data sharing statement initially provided

14/06/2019

Date results 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Kidney injury

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the end of each continuous renal replacement therapy treatment.

Primary outcome [2]

Hours of artificial filter life

Timepoint [2]

At the end of each continuous renal replacement therapy treatment via a medical record audit.

Secondary outcome [1]

Access pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.

Timepoint [1]

Continuous monitoring from commencement to end of continuous renal replacement therapy..

Secondary outcome [2]

Filter pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.

Timepoint [2]

Continuous monitoring from commencement to end of continuous renal replacement therapy..

Secondary outcome [3]

Return pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.

Timepoint [3]

Continuous monitoring from commencement to end of continuous renal replacement therapy..

Secondary outcome [4]

Effluent pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.

Timepoint [4]

Continuous monitoring from commencement to end of continuous renal replacement therapy..

Secondary outcome [5]

Replacement pressure value changes of the extracorporeal circuit as measured by the renal replacement therapy device.

Timepoint [5]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

Actual

26/11/2014

Date of last participant enrolment

Anticipated

Actual

14/06/2019

Date of last data collection

Anticipated

31/07/2019

Actual

14/06/2019

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Anaesthesia Intensive Care Trust Fund (Austin Hospital)

Address [1]

c/o Professor Rinaldo Bellomo
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria, 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg
Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/11/2014

Approval date [1]

26/11/2014

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/371009-Zhang et al - Patterns and mechanisms of artificial kidney failure during CRRT - Blood Purif 2016.pdf (Publication)

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

Email

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

Email

glenn.eastwood@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

Email

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Blood Purification: Patterns and mechanisms of art... [More Details]
Plain language summary	No		We aimed to describe the previously unstudied rela... [More Details]

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
939	Study results article	Yes		Blood Purification: Patterns and mechanisms of art... [More Details]
2826	Plain language summary	No		We aimed to describe the previously unstudied rela... [More Details]
5285	Study results article	Yes	https://doi.org/10.1159/000441968	Zhang L, Tanaka A, Zhu G, Baldwin I, Eastwood GM, ... [More Details]

Documents added automatically

No additional documents have been identified.