The Early Detection of Acute Renal Failure

• 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

Countries of recruitment

New Zealand

Contacts

• Name: Professor Zoltan Endre

• Name: Dr John Pickering

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 µmol/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

Source(s) of Monetary Support

Health Research Council of New Zealand

Secondary Sponsor(s)

Nil