ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610001012066

Ethics application status

Approved

Date submitted

12/02/2010

Date registered

18/11/2010

Date last updated

19/11/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

Early Detection of Acute Kidney Injury (EDAKI)

Scientific title

Early Detection of Acute Kidney Injury with Neutrophil Gelatinase Associated Lipocalin, Gamma-Glutamyl Transpeptidase, Albumin, Neopterin, Dihydroneopterin and other biomarkers: Reduction in false negative rates (EDAKI)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

EDAKI

Linked study record

Health condition

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

Acute Kidney Injury

Acute Renal Failure

Cardiac Arrest

Abdominal Aortic Aneurysm

Hypotension

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

No intervention. Prospective observational study of urinary and plasma biomarkers in the emergency department, intensive care unit, and at a 30 day follow up. Mortality will be assessed at one year.
Urinary biomarkers are taken from urine collected from catheterised patients in the Emergency Department, on entry to the Intensive Care Unit, then 4, 8, 16 hours, and 2, 4, 7 days later. There is no inconvenience to patients.
Plasma biomarkers are taken from blood sampled at the same time points, with the exception of the 4 and 8 hour samples, these samples are taken along with routine clinical blood collections. There is minimal inconvenience to patients.

Intervention code [1]

Not applicable

Comparator / control treatment

Comparator's are patients without Acute Kidney Injury

Control group

Active

Outcomes

Primary outcome [1]

Reduction of False Negative rate for prediction of Acute Kidney Injury (AKI) by sampling on entry to the Emergency Department (ED) compared with on entry to the Intensive Care Unit (ICU)

Timepoint [1]

Comparison between on entry to ED compared with on entry to ICU

Secondary outcome [1]

Receiver Operator Characteristic (ROC) plot analysis ("receiver-operating characteristic") will be used to compare the discriminative power of the biomarkers for AKI, need for Renal Replacement Therapy (RRT), Death (30 day).

Timepoint [1]

On entry to ED. On entry to the ICU. During ICU stay (7 days)

Eligibility

Key inclusion criteria

On entry to the ED:
(1) Cardiac Arrest within the preceding three hours AND/OR
(2) Ruptured Abdominal Aortic Aneurysm AND/OR
(3) Sustained hypotension (defined as systolic blood pressure (SBP) <90 mmHg or Mean Arterial Pressure (MAP) < 65 mmHg after 1000ml IV fluid challenge / 60 mins (including Intravenous (IV) fluids pre hospital)) AND/OR
(4) Profound hypotension (Systolic Blood Pressue (SBP) less than 60mmHg) of any duration.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) Age<16
(2) Moribund, not expected to survive 24 hours
(3) Likely to be discharged within 24 hours
(4) Drug overdose
(5) Treatment limitation order
(6) Receiving Renal Replacement Therapy
(7) More than 4 hours since entry to ED
(8) Inter-hospital transfer unless arrival in ED within <3 hours of event
(9) Non-consent

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

8/03/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Lotteries Health New Zealand

Address [1]

Lottery Health Research,
Department of Internal Affairs,
46 Waring Taylor Street,
PO Box 805,
Wellington,
New Zealand.

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago Christchurch

Address

PO Box 4345
Christchurch 8140

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Upper South B Regional Ethics Committee

Ethics committee address [1]

c/- Ministry of Health
PO Box 3877
Christchurch 8140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

07/10/2009

Ethics approval number [1]

URA/09/09/062

Summary

Brief summary

Lay Summary:
Acute Kidney Injury (AKI) occures in nearly half of all critically ill patients because of temporary loss of blood to the kidneys or damage from toxins.  Currently AKI is diagnosed by observing creatinine in the blood which increases in concentration 2-3 days after injury.  This delay in treatment can be fatal.  This study measures new biomarkers of AKI which indicate damage to the kidney within a few hours of injury.  Each biomarker reacts differently and tells us something different about the injury.  For example, albumin comes from the blood into the kidneys and out into the urine only when the filter mechanism is damaged.  GGT and NGAL are elevated in urine when there is specific damage to the tubules in which urine is formed in the kidney and neopterin tells us if there is inflammation in these tubules.  By measuring these markers in the emergency department we are measuring them as soon as possible after injury.  We then compare them to the later traditional clinical diagnosis of AKI.  The ultimate goal is to develop a panel of biomarkers which will detect AKI in all cases very soon after injury and so will allow early treatment and the saving of lives.

Trial website

Trial related presentations / publications

Endre ZH, Walker RJ, Pickering JW, Shaw GM, Frampton CM, Henderson SJ, Hutchison R, Mehrtens J, Robinson JM, Schollum JBW, Westhuyzen J, Celi LA, McGinley R, Campbell IJ, George PM (2010) Early intervention with erythropoietin does not affect the outcome of acute kidney injury (the EARLYARF trial). Kidney Int 77:1020-1030 (doi: 10.1038/ki.2010.25) 

Pickering JW and Endre ZH. (2009) Secondary outcomes of Acute Kidney Injury (AKI) Curr Op Crit Care, 15:488-97

Endre, ZH and Pickering JW. (2010) Outcome definitions in non-dialysis intervention and prevention trials in Acute Kidney Injury (AKI), Nephrol Dial Transpl, 25:107-118

Pickering, J.W., Endre, Z.H. (2010) Back-calculating baseline creatinine with MDRD misclassifies Acute Kidney Injury in the intensive care unit Clin J Am Soc Nephrol  5:1165-73 (doi:10.2215/CJN.08531109)

Nejat M., Pickering, J.W., Walker R.J., Endre, Z.H. (2010) Rapid detection of acute kidney injury by plasma cystatin C in the intensive care unit Nephrol Dial Transplant, 25:3283-3289 (doi:10.1093/ndt/gfq176)

Nejat M., Pickering J.W., Walker R.J., Westhuyzen J., Shaw G.M., Frampton C.M., Endre Z.H. (2010) Urinary cystatin C is diagnostic of acute kidney injury and sepsis, and predicts mortality in the intensive care unit. Critical Care, 14, R85, (doi:10.1186/cc9014)


Pickering JW and Endre ZH. (2009) RIFLE and AKIN –maintain the momentum and the GFR! (letter), Crit Care, 13:416 

Pickering JW, Frampton, C, Endre ZH. (2009) Evaluation of Trial Outcomes in Acute Kidney Injury by Creatinine Modelling, Clin J Am Soc Nephrol, 4:1705-1715 

Pickering JW and Endre ZH. (2009) GFR shot by RIFLE: errors in staging acute kidney injury. The Lancet, 373: p. 1318-19

Westhuyzen J, Endre ZH, Reece G, Reith DM, Saltissi D, Morgan TJ. Measurement of tubular enzymuria facilitates early detection of acute renal impairment in the intensive care unit. Nephrol Dial Transplant (2003) vol. 18 pp. 543-551

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Zoltan Endre

Address

Christchurch Kidney Research Group
Department of Medicine
University of Otago Christchurch
PO Box 4345
CHRISTCHURCH 8140

Country

New Zealand

Phone

+64 3 364 1847

Fax

Rowena.Fisher@otago.ac.nz

Contact person for scientific queries

Name

Zoltan Endre

Address

Christchurch Kidney Research Group
Department of Medicine
University of Otago Christchurch
PO Box 4345
CHRISTCHURCH 8140

Country

New Zealand

Phone

+64 3 364 1847

Fax

Rowena.Fisher@otago.ac.nz

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The clinical utility window for acute kidney injury biomarkers in the critically ill.	2014	https://dx.doi.org/10.1186/s13054-014-0601-2

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

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