Trial Review

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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] 253109 0
None
Universal Trial Number (UTN)
Trial acronym
EDAKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 251999 0
Acute Renal Failure 252000 0
Cardiac Arrest 256683 0
Abdominal Aortic Aneurysm 256684 0
Hypotension 256685 0
Condition category
Condition code
Renal and Urogenital 252192 252192 0 0
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] 241410 0
Not applicable
Comparator / control treatment
Comparator's are patients without Acute Kidney Injury
Control group
Active

Outcomes
Primary outcome [1] 253071 0
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] 253071 0
Comparison between on entry to ED compared with on entry to ICU
Secondary outcome [1] 257908 0
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] 257908 0
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?
No
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] 2267 0
New Zealand
State/province [1] 2267 0
Canterbury

Funding & Sponsors
Funding source category [1] 243872 0
Charities/Societies/Foundations
Name [1] 243872 0
Lotteries Health New Zealand
Country [1] 243872 0
New Zealand
Primary sponsor type
University
Name
University of Otago Christchurch
Address
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 255829 0
None
Name [1] 255829 0
Address [1] 255829 0
Country [1] 255829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243994 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 243994 0
c/- Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 243994 0
New Zealand
Date submitted for ethics approval [1] 243994 0
Approval date [1] 243994 0
07/10/2009
Ethics approval number [1] 243994 0
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 30385 0
Address 30385 0
Country 30385 0
Phone 30385 0
Fax 30385 0
Email 30385 0
Contact person for public queries
Name 13632 0
Zoltan Endre
Address 13632 0
Christchurch Kidney Research Group
Department of Medicine
University of Otago Christchurch
PO Box 4345
CHRISTCHURCH 8140
Country 13632 0
New Zealand
Phone 13632 0
+64 3 364 1847
Fax 13632 0
Email 13632 0
Rowena.Fisher@otago.ac.nz
Contact person for scientific queries
Name 4560 0
Zoltan Endre
Address 4560 0
Christchurch Kidney Research Group
Department of Medicine
University of Otago Christchurch
PO Box 4345
CHRISTCHURCH 8140
Country 4560 0
New Zealand
Phone 4560 0
+64 3 364 1847
Fax 4560 0
Email 4560 0
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
SourceTitleYear of PublicationDOI
EmbaseThe clinical utility window for acute kidney injury biomarkers in the critically ill.2014https://dx.doi.org/10.1186/s13054-014-0601-2
N.B. These documents automatically identified may not have been verified by the study sponsor.