NCT01486563

Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Regional Hospital Holstebro · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.

Detailed description

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Voluven (Hydroxyethyl starch 130/0,4)	7,5 ml/kg in the first hour and then 5 ml/kg
DRUG	Sodium Chloride 9 mg/ml	7,5 ml/kg in the first hour and then 5 ml/kg

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-12-06
• Last updated: 2013-09-17

Locations

1 site across 1 country: Denmark