Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000394549
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
28/04/2015
Date last updated
28/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Renal Replacement Therapy Intensity in Severe Acute Kidney Injury: An Individual Patient Data Meta-analysis of Randomized Trials
Scientific title
Renal Replacement Therapy Intensity in Severe Acute Kidney Injury and its Effect on All-cause Mortality and Recovery to Dialysis Independence: An Individual Patient Data Meta-analysis of Randomized Trials
Secondary ID [1] 286500 0
Nil known
Universal Trial Number (UTN)
Trial acronym
IMPROVE-AKI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe acute kidney injury requiring renal replacement therapy 294714 0
Condition category
Condition code
Renal and Urogenital 295002 295002 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Higher intensity haemodialysis, a prescribed dose of 35 to 48 ml/kg/h or defined as published in the original publications
Intervention code [1] 291593 0
Not applicable
Comparator / control treatment
Standard intensity haemodialysis, a prescribed dose of 20 to 25 ml/kg/h or defined as published in the original publications
Control group
Dose comparison

Outcomes
Primary outcome [1] 294754 0
All-cause mortality
Timepoint [1] 294754 0
At trial specific follow-up time points.
Secondary outcome [1] 313994 0
Renal replacement therapy (RRT) dependence, defined as the proportion of patients who were still RRT dependent at 7, 14, 28, 60 and 90 days, time to recovery to RRT independence
Timepoint [1] 313994 0
At trial specific follow-up time points

Eligibility
Key inclusion criteria
All randomized controlled trials assessing the effects of different doses of renal replacement therapy (RRT) in patients with AKI.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chronic kidney disease

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Individual patient data meta-analysis. Individual patient data from each eligible trial was pooled and all the outcomes were analyzed based on the intention to treat principle, taking all randomized participants into consideration. The effect of different dialysis dosing intensities upon mortality and dialysis outcomes was analyzed using log-binomial regression with a random effects model and random study-by-treatment interaction.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 6794 0
United States of America
State/province [1] 6794 0
Country [2] 6795 0
Netherlands
State/province [2] 6795 0
Country [3] 6796 0
Germany
State/province [3] 6796 0
Country [4] 6797 0
Italy
State/province [4] 6797 0
Country [5] 6798 0
Switzerland
State/province [5] 6798 0

Funding & Sponsors
Funding source category [1] 291062 0
Government body
Name [1] 291062 0
Australian National Health and Medical Research Council (NHMRC) project grant
Country [1] 291062 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The George Institute for Global Health
Address
Level 10, King George V Building, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 289745 0
None
Name [1] 289745 0
Address [1] 289745 0
Country [1] 289745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292648 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 292648 0
73 Miller Street
North Sydney NSW 2060
Australia
Ethics committee country [1] 292648 0
Australia
Date submitted for ethics approval [1] 292648 0
Approval date [1] 292648 0
15/04/2011
Ethics approval number [1] 292648 0
LNR2011/004

Summary
Brief summary
Renal replacement (RRT) dose intensity may affect patient and kidney outcomes in severe acute kidney injury (AKI) but randomized controlled trial (RCTs) have been contradictory for mortality and inadequately powered for renal outcomes. The Investigation, Management, Prognosis, Recovery, Observation, Value and Evaluation of Acute Kidney Injury (IMPROVE-AKI) collaboration brings together investigators from current randomised clinical trials of RRT dose intensity in AKI to perform IPDMA of the effects of RRT dose intensity.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 390 390 0 0
/AnzctrAttachments/368336-IPD%20Renal%20SAP%20v2%2010Apr12[2].docx

Contacts
Principal investigator
Name 56402 0
Prof Rinaldo Bellomo
Address 56402 0
10-12 Ievers Terrace, Carlton VIC 3053
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Country 56402 0
Australia
Phone 56402 0
61-3-9496 5992
Fax 56402 0
Email 56402 0
[email protected]
Contact person for public queries
Name 56403 0
Prof Rinaldo Bellomo
Address 56403 0
10-12 Ievers Terrace, Carlton VIC 3053,
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Country 56403 0
Australia
Phone 56403 0
61-3-9496 5992
Fax 56403 0
Email 56403 0
[email protected]
Contact person for scientific queries
Name 56404 0
Prof Rinaldo Bellomo
Address 56404 0
10-12 Ievers Terrace, Carlton VIC 3053,
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Country 56404 0
Australia
Phone 56404 0
61-3-9496 5992
Fax 56404 0
Email 56404 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23378Other https://academic.oup.com/ndt/article/33/6/1017/4656150 
23822Other    The published manuscript via the following link h... [More Details]

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4535Study results articleYes Ying Wang, Martin Gallagher, Qiang Li, Serigne Lo,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRenal replacement therapy intensity for acute kidney injury and recovery to dialysis independence: A systematic review and individual patient data meta-analysis.2018https://dx.doi.org/10.1093/ndt/gfx308
N.B. These documents automatically identified may not have been verified by the study sponsor.