Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically
ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far
acute kidney injury has been diagnosed based on creatinine measurements, but new technology
allows for earlier diagnosis using measurements of biomarkers in urine.
The purpose of this project is to investigate HES's potential toxicity and effects on the
circulation and kidneys using measurements of biomarkers specific for toxicity and for the
sodium/water balance in the urine and by measurements of vasoactive hormones in the blood
after administration of HES 130/0.4
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
u-NGAL
The main objective for the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity
2-4 hours
Yes
Anne Sophie P. Kancir, MD PhD
Principal Investigator
Holstebro Regional Hospital
Denmark: Danish Medicines Agency
ASK-2-2011
NCT01486563
January 2012
June 2013
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