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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
28/05/2020
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] 300998 0
None
Universal Trial Number (UTN)
Trial acronym
PERFORM-AKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 317039 0
Condition category
Condition code
Renal and Urogenital 315201 315201 0 0
Kidney disease
Public Health 315418 315418 0 0
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 including 4 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. 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] 317319 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323457 0
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 4 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] 323457 0
At two weeks after the initial renal consultation
Secondary outcome [1] 382005 0
Clinical aetiology of AKI episodes, which will be documented in the clinical notes and provided by the treating nephrologist.
Timepoint [1] 382005 0
At two weeks after the initial renal consultation
Secondary outcome [2] 382525 0
The treatments that are employed, which will be documented in the clinical notes and provided by the treating nephrologist.
Timepoint [2] 382525 0
At two weeks after the initial renal consultation
Secondary outcome [3] 382526 0
The renal outcomes of participants, which will be documented in the clinical notes and provided by the treating nephrologist.
Timepoint [3] 382526 0
At two weeks after the initial renal consultation
Secondary outcome [4] 382527 0
Mortality, which will be documented in the clinical notes and provided by the treating nephrologist.
Timepoint [4] 382527 0
At two weeks after the initial renal consultation
Secondary outcome [5] 383090 0
Mortality, which will be collected via data linkage.
Timepoint [5] 383090 0
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
Gender
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
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
Not yet 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)
NSW
Recruitment hospital [1] 16446 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 29988 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 305442 0
Other Collaborative groups
Name [1] 305442 0
The George Institute for Global Health
Address [1] 305442 0
Level 5/1 King Street, Newtown NSW 2042
Country [1] 305442 0
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] 305840 0
None
Name [1] 305840 0
Address [1] 305840 0
Country [1] 305840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305759 0
Sydney Local Health District Human Research Ethics Committee – CRGH
Ethics committee address [1] 305759 0
Concord Repatriation General Hospital (CRGH)
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 305759 0
Australia
Date submitted for ethics approval [1] 305759 0
Approval date [1] 305759 0
20/12/2019
Ethics approval number [1] 305759 0

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 101498 0
Dr Amanda Y Wang
Address 101498 0
The Renal and Metabolic Division, The George Institute for Global Health, Australia
Level 5/1 King St, Newtown NSW 2042
Country 101498 0
Australia
Phone 101498 0
+61 2 98581899
Fax 101498 0
Email 101498 0
awang@georgeinstitute.org.au
Contact person for public queries
Name 101499 0
Dr Amanda Y Wang
Address 101499 0
The Renal and Metabolic Division, The George Institute for Global Health, Australia
Level 5/1 King St, Newtown NSW 2042
Country 101499 0
Australia
Phone 101499 0
+61 2 98581899
Fax 101499 0
Email 101499 0
awang@georgeinstitute.org.au
Contact person for scientific queries
Name 101500 0
Dr Amanda Y Wang
Address 101500 0
The Renal and Metabolic Division, The George Institute for Global Health, Australia
Level 5/1 King St, Newtown NSW 2042
Country 101500 0
Australia
Phone 101500 0
+61 2 98581899
Fax 101500 0
Email 101500 0
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 other documents available
Summary results
No Results