World Health Organization site
Skip Navigation Links

Main
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 22 February 2013
Main ID:  ACTRN12606000032550
Date of registration: 24/01/2006
Primary sponsor: Government funding body Health Research Council of New Zealand
Public title: The Early Detection of Acute Renal Failure EARLY ARF 1
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.
Date of first enrolment: 23/01/2006
Target sample size: 450
Recruitment status: Closed: follow-up complete
URL:  http://www.anzctr.org.au/ACTRN12606000032550.aspx
Study type:  Observational
Study design:   
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
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 ┬Ámol/L 3 (General ICU admissions) consecutive admissions.
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).

Age minimum: 16 Years
Age maximum: 0 Not stated
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Acute Renal Failure
Intervention(s)
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).
Primary Outcome(s)
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.
Secondary Outcome(s)
Dialysis need at ICU exit
Enrollment on EARLY ARF2 (The related interventional study - see separate registration).
Length of ICU stay
Mortality
Secondary ID(s)
Source(s) of Monetary Support
Health Research Council of New Zealand
Secondary Sponsor(s)
Nil
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history