ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

All-cause mortality

Timepoint [1]

At trial specific follow-up time points.

Secondary outcome [1]

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]

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?

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]

United States of America

State/province [1]

Country [2]

Netherlands

State/province [2]

Country [3]

Germany

State/province [3]

Country [4]

Italy

State/province [4]

Country [5]

Switzerland

State/province [5]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian National Health and Medical Research Council (NHMRC) project grant

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSW Population and Health Services Research Ethics Committee

Ethics committee address [1]

73 Miller Street
North Sydney NSW 2060
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/04/2011

Ethics approval number [1]

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]

/AnzctrAttachments/368336-IPD%20Renal%20SAP%20v2%2010Apr12[2].docx

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

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

Australia

Phone

61-3-9496 5992

Fax

[email protected]

Contact person for public queries

Name

Rinaldo Bellomo

Address

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

Australia

Phone

61-3-9496 5992

Fax

[email protected]

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

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

Australia

Phone

61-3-9496 5992

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Ying Wang, Martin Gallagher, Qiang Li, Serigne Lo,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Renal replacement therapy intensity for acute kidney injury and recovery to dialysis independence: A systematic review and individual patient data meta-analysis.	2018	https://dx.doi.org/10.1093/ndt/gfx308

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically