Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Voluven (Hydroxyethyl starch 130/0,4); Drug: Sodium Chloride 9 mg/ml

• Registration Number: NCT01486563
• Lead Sponsor: Regional Hospital Holstebro

Brief 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

Study Timeline

• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-04
• Study First Posted: 2011-12-06
• Study Start: 2012-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voluven (Hydroxyethyl starch 130/0,4)	Voluven (Hydroxyethyl starch 130/0,4)	Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Sodium Chloride 9 mg/ml	Sodium Chloride 9 mg/ml	Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Primary Outcome Measures

Name	Time	Method
u-NGAL	2-4 hours	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

Secondary Outcome Measures

Name	Time	Method
u-Kim 1, u- FABP	2-4 hours	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	2-4 hours	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	2-4 hours	Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
SBP, DBP, heartrate	2-4 hours	Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy

Trial Locations

Locations (1)

Medicinsk forskningsafsnit, Regionshospitalet Holstebro; 🇩🇰 Holstebro, Denmark