Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

• u-Kim 1, u- FABP [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
  Another objective of the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFABP, which are also biomarkers of nephrotoxicity
• FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
  Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy
• PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
  Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
• SBP, DBP, heartrate [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
  Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy

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.

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

• Drug: Voluven (Hydroxyethyl starch 130/0,4)
  7,5 ml/kg in the first hour and then 5 ml/kg
  Other Names:

  • Voluven
  • Venofundin
  • Hydroxyethyl starch
• Drug: Sodium Chloride 9 mg/ml
  7,5 ml/kg in the first hour and then 5 ml/kg
  Other Name: Istone saline solution

• Active Comparator: Voluven (Hydroxyethyl starch 130/0,4)
  Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
  Intervention: Drug: Voluven (Hydroxyethyl starch 130/0,4)
• Placebo Comparator: Sodium Chloride 9 mg/ml
  Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
  Intervention: Drug: Sodium Chloride 9 mg/ml

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