Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
Inclusion Criteria:
- Age > 18 years
- Males
- Indication for radical prostatectomy
Exclusion Criteria:
- Blood donation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Outcome Measure:
u-NGAL
Outcome Description:
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
Outcome Time Frame:
2-4 hours
Safety Issue:
Yes
Principal Investigator
Anne Sophie P. Kancir, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Holstebro Regional Hospital
Authority:
Denmark: Danish Medicines Agency
Study ID:
ASK-2-2011
NCT ID:
NCT01486563
Start Date:
January 2012
Completion Date:
June 2013
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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