ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000621910

Ethics application status

Approved

Date submitted

13/04/2020

Date registered

28/05/2020

Date last updated

15/04/2024

Date data sharing statement initially provided

28/05/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Incidence and risk factors of acute renal failure

Scientific title

Epidemiology, risk factors and outcomes of Acute Kidney Injury (PERFORM-AKI): feasibility of prospective data collection

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PERFORM-AKI

Linked study record

Health condition

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

Acute Kidney Injury

Condition category

Condition code

Renal and Urogenital

Kidney disease

Public Health

Epidemiology

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a prospective cohort study involving 5 renal units in NSW and assessing the incidence, risk factors and clinical outcomes of patients with acute kidney injury in the non-ICU setting. Study investigators will collect data at baseline and 2 weeks after the initial renal consultation (or at discharge, whichever is earliest). Data linkage will be performed to identify mortality and renal recovery data at 12 months post acute kidney injury. Participants are not required to complete any questionnaires.

Intervention code [1]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome is the feasibility of prospective collection of the clinical details and outcomes of patients with AKI in the non-ICU setting at 5 teaching hospitals. The diagnosis and staging of AKI will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 clinical practice guideline definition using measurement of serum creatinine and urine output. Feasibility will be assessed using the percentage (>80%) of completion of the data collection in each site.

Timepoint [1]

At two weeks after the initial renal consultation, or at discharge, whichever is earliest.

Secondary outcome [1]

Clinical aetiology of AKI episodes, which will be documented in the clinical notes and provided by the treating nephrologist.

Timepoint [1]

At two weeks after the initial renal consultation, or at discharge, whichever is earliest.

Secondary outcome [2]

The treatments that are employed, which will be documented in the clinical notes and provided by the treating nephrologist.

Timepoint [2]

At two weeks after the initial renal consultation, or at discharge, whichever is earliest.

Secondary outcome [3]

The renal outcomes of participants, which will be documented in the clinical notes and provided by the treating nephrologist.

Timepoint [3]

At two weeks after the initial renal consultation, or at discharge, whichever is earliest.

Secondary outcome [4]

Mortality, which will be documented in the clinical notes and provided by the treating nephrologist.

Timepoint [4]

At two weeks after the initial renal consultation, or at discharge, whichever is earliest.

Secondary outcome [5]

Mortality, which will be collected via data linkage.

Timepoint [5]

12 months post AKI

Secondary outcome [6]

Dialysis dependence/renal function, which will be collected via data linkage.

Timepoint [6]

Secondary outcome [7]

Dialysis dependence/renal function, which will be collected via data linkage.

Timepoint [7]

12 months post AKI

Eligibility

Key inclusion criteria

All adult inpatients diagnosed with AKI in any of the participating Renal Units, either during an admission under the participating Unit or as an external consultation by the Renal Unit for a patient under the care of another hospital Unit during their hospital stay.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

• Patient with AKI initially diagnosed and managed in the ICU.
• Patient < 18 years of age at the time of AKI diagnosis

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The number of incident AKI diagnoses, the nature of these events, including aetiology (e.g. sepsis, drugs, etc) and outcomes of AKI will be calculated using the event rate. Multivariate logistic regression analysis will be performed to examine clinical factors predictive of mortality.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2020

Actual

23/02/2021

Date of last participant enrolment

Anticipated

Actual

18/10/2023

Date of last data collection

Anticipated

Actual

2/11/2023

Sample size

Target

600

Accrual to date

Final

639

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment hospital [2]

Prince of Wales Hospital - Randwick

Recruitment hospital [3]

Ryde Hospital - Eastwood

Recruitment hospital [4]

Canterbury Hospital - Campsie

Recruitment hospital [5]

Sydney Adventist Hospital - Wahroonga

Recruitment postcode(s) [1]

2139 - Concord

Recruitment postcode(s) [2]

2031 - Randwick

Recruitment postcode(s) [3]

2122 - Eastwood

Recruitment postcode(s) [4]

2194 - Campsie

Recruitment postcode(s) [5]

2076 - Wahroonga

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The George Institute for Global Health

Address [1]

Level 5/1 King Street, Newtown NSW 2042

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

The George Institute for Global Health

Address

Level 5/1 King St, Newtown Australia NSW 2042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee – CRGH

Ethics committee address [1]

Concord Repatriation General Hospital (CRGH), Building 20, Hospital Rd, Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/12/2019

Ethics approval number [1]

Summary

Brief summary

The incidence of Acute Kidney Injury (AKI) is increasing, with Australian and US Medicare data illustrating striking increases over the decade following 2000. Up to 20% of adult patients experience AKI during their hospitalization, with mortality rates as high as 45%, and  AKI is a global healthcare issue that has significant impacts on patients’ quality of life. In the absence of proven therapies to prevent or even treat AKI, it is likely that the current growth in incidence will continue into coming years. Almost all the randomised trial evidence in AKI arises from patients with severe AKI requiring renal replacement therapy (RRT) in the ICU setting. The non-ICU burden of AKI is much larger, such that interventions in this area are likely to have a much greater impact upon AKI globally. In addition, as novel treatments are developed to address the poor outcomes of AKI, these non-ICU patients will be central to the testing of these treatments.
Current literature regarding non-ICU AKI are mainly derived from retrospective studies and administrative data. Two large administrative studies have demonstrated an approximate rise in incidence of AKI by 20 episodes per 1000 discharges between 1990 and 2000, with local Australian and New Zealand  data also showing similar increases in ICU patients. However, the incidence of AKI in the non-ICU setting using a prospective study is poorly-known due to underreporting, differences in the AKI definition and case mix.
The PERFORM-AKI study will provide initial unique insights into the burden of non-ICU AKI and form the basis of understanding the potentially remediable factors that might be amendable to modification in order to improve long-term outcomes of survivors following AKI.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Amanda Y Wang

Address

The George Institute for Global Health, PO Box M201, Missenden Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8052 4573

Fax

Email

awang@georgeinstitute.org.au

Contact person for public queries

Name

Amanda Y Wang

Address

The George Institute for Global Health, PO Box M201, Missenden Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8052 4573

Fax

Email

awang@georgeinstitute.org.au

Contact person for scientific queries

Name

Amanda Y Wang

Address

The George Institute for Global Health, PO Box M201, Missenden Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 8052 4573

Fax

Email

awang@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

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.