Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000032550
Ethics application status
Approved
Date submitted
19/01/2006
Date registered
24/01/2006
Date last updated
14/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Early Detection of Acute Renal Failure
Scientific title
A multi-centre logitudinal observational study to evaluate the sensitivity and specificity of novel biomarkers in the early detection of acute renal failure in intensive care unit patients when compared with conventional diagnostic tests following an acute kidney injury.
Universal Trial Number (UTN)
Trial acronym
EARLY ARF 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 995 0
Condition category
Condition code
Renal and Urogenital 1070 1070 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a two centre observational study in which the sensitivity and specificity of novel urinary and plasma biomarkers will be compared with conventional indicators of acute renal failure. Biomarkers will be assessed with varying degrees of frequency. 6 or 12 hourly measurements of novel and conventional biomarkers will be undertaken for the first 24 hours after admission to the intensive care unit. Thereafter, samples will be collected on a daily basis for the next 6 days (or until the patient is discharged from the intensive care unit. Patients reaching a pre determined Gamma-Glutamyl Transpeptidase (GGT)/Alkaline Phosphatase (AP) index will be enrolled in a second study (see entry for EARLY ARF 2).
Intervention code [1] 847 0
Early detection / Screening
Comparator / control treatment
Biomarkers in those with Acute Renal Failure will be compared with those in patients without Acute Renal Failure
Control group
Historical

Outcomes
Primary outcome [1] 1433 0
The primary outcome of this study will be the early detection of acute renal failure using any one or a combination of the following biomarkers: Urinary creatinine, GGT, AP, Urea, Cystatin C, Kidney Injury Marker1 (KIM1), Inter Leukin-18 (IL18), Aquaporins (AQP) 1 and 2 and Neutrophil Gelatinase-associated Lipocalin (NGAL). The sensitivity and specificity of these measures will be matched against conventional diagnostic markers for acute renal failure.
Timepoint [1] 1433 0
All of the above biomarkers will be measured, with varying frequency, over a period of up to 7 days.
Secondary outcome [1] 2535 0
Mortality
Timepoint [1] 2535 0
30,90,180,365 days
Secondary outcome [2] 2536 0
Length of ICU stay
Timepoint [2] 2536 0
30,90,180,365 days
Secondary outcome [3] 2537 0
Dialysis need at ICU exit
Timepoint [3] 2537 0
End of ICU stay
Secondary outcome [4] 2538 0
Enrollment on EARLY ARF2 (The related interventional study - see separate registration).
Timepoint [4] 2538 0
End of ICU stay

Eligibility
Key inclusion criteria
1. (cardio-thoracic surgery sub group) Undergoing cardio-thoracic surgery involving cardiac-pump bypass plus one or more of the following:a) diabetesb) extra-cardiac vascular diseasec) creatinine >150 µmol/L 3 (General ICU admissions) consecutive admissions.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
\1. expected length of stay <24 hours2. The patient is not expected to survive longer than 72 hours3. Frank haematuria4. active cytotoxic chemotherapy in progress5. Patient has rhabdomyolysis and/myoglobinuria6. Patient is already receiving renal replacement therapy7. Consent is unobtainable8. Pre-existing severe renal disease (serum creatinine of >0.345 mmol/L) or a rise of >3 times from baseline serum creatinine (if available)9. Anuria or output less than 0.3 ml/Kg/hr at 4 hours after admission (following correction if underfilled).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment outside Australia
Country [1] 260 0
New Zealand
State/province [1] 260 0

Funding & Sponsors
Funding source category [1] 1170 0
Government body
Name [1] 1170 0
Health Research Council of New Zealand
Country [1] 1170 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 1031 0
None
Name [1] 1031 0
Nil
Address [1] 1031 0
Country [1] 1031 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2489 0
Multi-regional Ethics Committee of New Zealand
Ethics committee address [1] 2489 0
Ethics committee country [1] 2489 0
New Zealand
Date submitted for ethics approval [1] 2489 0
Approval date [1] 2489 0
Ethics approval number [1] 2489 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35445 0
Address 35445 0
Country 35445 0
Phone 35445 0
Fax 35445 0
Email 35445 0
Contact person for public queries
Name 10036 0
Dr John Pickering
Address 10036 0
Research Manager/Research Fellow
Christchurch Kidney Research Group Department of Medicine Christchurch School of Medicine and Health Sciences PO Box 4345 Christchurch 8001
Country 10036 0
New Zealand
Phone 10036 0
+64 3 3641112
Fax 10036 0
+64 3 3640935
Email 10036 0
john.pickering@otago.ac.nz
Contact person for scientific queries
Name 964 0
Professor Zoltan Endre
Address 964 0
Head of Department
Christchurch Kidney Research Group
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8001
Country 964 0
New Zealand
Phone 964 0
+64 3 3641847
Fax 964 0
+64 3 3640935
Email 964 0
zoltan.endre@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
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