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Trial registered on ANZCTR


Registration number
ACTRN12618002044202
Ethics application status
Approved
Date submitted
17/12/2018
Date registered
20/12/2018
Date last updated
21/01/2019
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian Follow-up Tracking and Enhancing Recovery after Acute Kidney Injury (AFTER-AKI)
Scientific title
A multi-centre, pilot randomised controlled trial of a post-acute kidney injury care bundle in patients at high risk of major adverse kidney events
Secondary ID [1] 296574 0
None
Universal Trial Number (UTN)
Trial acronym
AFTER-AKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 310426 0
Condition category
Condition code
Renal and Urogenital 309143 309143 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention arm will be reviewed one-on-one by a nephrologist (or a nephrology advanced trainee under the supervision of a nephrologist) in an outpatient clinic within 30 days (± 2 weeks) of discharge from the acute hospital. This will be in addition to standard care. Reviews will last for 20 to 30 minutes and will occur every 3 months until the end of the study, with the final review occurring 12 months after enrolment (+ or - two weeks). At each clinic visit, a post-AKI care bundle will be implemented, based on international consensus guidelines for the prevention of CKD progression and cardiovascular risk. The care bundle includes:

• Use of renin-angiotensin-aldosterone blockers according to the recommendations made by the Kidney Disease: Improving Global Outcomes (KDIGO) or National Heart Foundation of Australia guidelines (proteinuria, reduced left ventricular systolic function, coronary heart disease). The choice of agent, dose and frequency will be at the discretion of the clinician.
• Targeted blood pressure control according to the recommendations made by the KDIGO or National Heart Foundation of Australia guidelines (<130/80mmHg in patients with proteinuria or cardiovascular disease; <140/90mmHg in other patients)
• Assessment of cardiovascular risk using www.cvdcheck.org.au/calculator
• Optimisation of cardiovascular risk using antiplatelet agents, cardioselective beta blockers and statins, according to the recommendations made by the KDIGO and National Heart Foundation of Australia guidelines. The choice of agent, dose and frequency will be at the discretion of the clinician.
• Rationalisation of medications by ensuring that all non-essential nephrotoxic agents are discontinued and that the dose of all medications is appropriate for the patient’s level of renal function
• Review of volume state by clinical examination
• Targeted glycaemic control, as recommended by the KDIGO guidelines (HbA1c below 7.0%), through diet control, oral hypoglycaemic agents and/or insulin therapy
• Implementation of healthy lifestyle interventions, including encouraging smoking cessation; limitation of daily sodium intake to less than 2g/day and daily alcohol intake to no more than 2 standard drinks for males and no more than 1 standard drink for females; regular moderate-intensity exercise (30 minutes on most days); and targeting a body mass index between 18.5 to 25kg/m2

Adherence to the bundle will be measured at the level of the clinician; that is, the number of interventions within the bundle that are addressed/performed at each visit. Low-risk individuals will be eligible for review every 6 months (with a blood and urine test at 3 months). To be considered low risk, individuals must meet all of the following criteria:

• Baseline eGFR >60ml/min/1.73m2
• Return of creatinine to within 25% of baseline
• All CKD prevention strategies are in place and all cardiovascular risk factors are optimised
• No serious adverse events have occurred since the last visit
Intervention code [1] 312922 0
Treatment: Other
Comparator / control treatment
Patients randomised to the comparator arm will receive standard care. Standard care is defined as the care that the patient would have received had they not been involved in the study. For the majority of patients, post-discharge follow-up with be performed by a patient’s local medical officer. Patients allocated to the comparator arm can still receive follow-up by a nephrologist, if referred through the routine referral pathway by their inpatient team or local medical officer, however they will not attend the post-AKI clinic or be managed with the post-AKI care bundle (i.e. the intervention).
Control group
Active

Outcomes
Primary outcome [1] 308127 0
Recruitment rate, defined as the proportion of eligible patients who are enrolled in the study
Timepoint [1] 308127 0
Single assessment at the time of final patient enrolment
Secondary outcome [1] 354006 0
Major adverse kidney event, defined as the composite of progressive chronic kidney disease (>25% decrease in eGFR), end-stage kidney disease (eGFR <15ml/min/1.73m2 or the requirement for renal replacement therapy), or death identified by telephone follow-up and/or linkage to medical records
Timepoint [1] 354006 0
Single assessment at 12 months post-discharge
Secondary outcome [2] 354007 0
Progressive chronic kidney disease, defined as a greater than 25% reduction in eGFR from baseline, and assessed using blood tests
Timepoint [2] 354007 0
Single assessment at 12 months post-discharge
Secondary outcome [3] 354008 0
End-stage kidney disease, defined as an eGFR <15ml/min/1.73m2 or the requirement for renal replacement therapy, and assessed using blood tests and medical records
Timepoint [3] 354008 0
Single assessment at 12 months post-discharge
Secondary outcome [4] 354009 0
Death, identified by telephone follow-up and/or linkage to medical records
Timepoint [4] 354009 0
Single assessment at 12 months post-discharge
Secondary outcome [5] 354010 0
Hospitalisation, assessed by medical records and patient interview
Timepoint [5] 354010 0
Single assessment at 12 months post-discharge
Secondary outcome [6] 354011 0
Cardiovascular event, defined as hospitalisation for heart failure, non-fatal acute myocardial infarct, non-fatal ischaemic stroke, non-fatal ischaemic limb, or coronary revascularisation procedure, and assessed using medical records
Timepoint [6] 354011 0
Single assessment at 12 months post-discharge
Secondary outcome [7] 354012 0
Recurrent acute kidney injury, as defined by Kidney Disease Improving Global Outcomes definition, and assessed using blood tests
Timepoint [7] 354012 0
Single assessment at 12 months post-discharge
Secondary outcome [8] 354013 0
Frailty, as defined by Dalhousie frailty score
Timepoint [8] 354013 0
Single assessment at 12 months post-discharge
Secondary outcome [9] 354014 0
Eligibility rate, defined as the proportion of screened patients who are eligible for the study
Timepoint [9] 354014 0
Single assessment at the time of final patient enrolment
Secondary outcome [10] 354015 0
Protocol adherence, defined as the proportion of interventions which are applied, and assessed using an audit of nephrologist behaviour
Timepoint [10] 354015 0
Single assessment at 12 months post-discharge
Secondary outcome [11] 355082 0
Adverse event (hyperkalemia, hypoglycemia, hypotension) requiring intervention. These outcomes will be defined based on blood tests, patient blood glucose diaries, and clinic blood pressure measurements.
Timepoint [11] 355082 0
Single assessment at the end of the study (defined as the last visit of the last patient)

Eligibility
Key inclusion criteria
ALL of the following:
1. Adult patients admitted to ICU or CCU
2. Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or 3 AKI
3. Alive and independent of RRT for 72 hours at discharge with no plan for RRT following discharge from hospital
4. Written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ANY of the following:
1. Age less than 18 years
2. Life expectancy <90 days
3. Baseline eGFR <30mL/min/1.73m2 (or no eGFR within 12 months)
4. Kidney transplant recipient
5. AKI due to suspected or proven glomerulonephritis, vasculitis, tubulointerstitial nephritis, thrombotic microangiopathy, pregnancy, myeloma, or hepatorenal syndrome
6. Previously enrolled in this study
7. Previously reviewed by a nephrologist within the preceding 12 months with the intention of ongoing follow-up

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Web-based allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence with randomly permuted blocks of 2, 4 or 6 patients
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Feasibility outcomes will be examined as proportions with confidence intervals. The difference in the number of participants with a major adverse kidney event, a 25% reduction in eGFR from baseline, end-stage kidney disease and death at 12 months will be compared using the Chi-square test statistic. The Kaplan Meier method will be used to generate event-free survival curves for ESKD and death, and the difference between groups will be assessed by the log-rank test. Time-to-event analyses will be performed using Cox (death) and competing risk regression (ESKD; death will be a competing risk) models. Time-to-event analyses will not be possible for MAKE or a 25% reduction in eGFR since data for eGFR will not be collected during the study for the control group. Hospitalisation, cardiovascular event, and recurrent AKI rates will be compared by negative binomial regression.

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)
QLD,VIC
Recruitment hospital [1] 12423 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 12424 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 12425 0
The Northern Hospital - Epping
Recruitment hospital [4] 12426 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 12427 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 24697 0
3084 - Heidelberg
Recruitment postcode(s) [2] 24698 0
3168 - Clayton
Recruitment postcode(s) [3] 24699 0
3076 - Epping
Recruitment postcode(s) [4] 24700 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 24701 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 301152 0
Hospital
Name [1] 301152 0
Austin Health
Address [1] 301152 0
145 Studley Rd,, Heidelberg VIC 3084
Country [1] 301152 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Rd,, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 301172 0
None
Name [1] 301172 0
Address [1] 301172 0
Country [1] 301172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301900 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301900 0
145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 301900 0
Australia
Date submitted for ethics approval [1] 301900 0
05/09/2018
Approval date [1] 301900 0
17/12/2018
Ethics approval number [1] 301900 0
HREC/45541/Austin-2018

Summary
Brief summary
Acute kidney injury is an increasingly common complication of acute illness in hospitalised patients. In the future, it can lead to chronic kidney disease, end-stage kidney disease, and death. The aim of this study is to investigate whether specialised nephrology follow-up after acute kidney injury is feasible and whether it is effective and reducing the long-term complications of this disease. The specialised nephrology follow-up includes a bundle of care aimed at addressing risk factor for chronic kidney disease and cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88486 0
Prof Rinaldo Bellomo
Address 88486 0
Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
Country 88486 0
Australia
Phone 88486 0
+61394965000
Fax 88486 0
+61394963932
Email 88486 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 88487 0
Dr Emily See
Address 88487 0
Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
Country 88487 0
Australia
Phone 88487 0
+61394965000
Fax 88487 0
Email 88487 0
emily.see@austin.org.au
Contact person for scientific queries
Name 88488 0
Dr Emily See
Address 88488 0
Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
Country 88488 0
Australia
Phone 88488 0
+61394965000
Fax 88488 0
Email 88488 0
emily.see@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results