Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Voluven (Hydroxyethyl starch 130/0,4)
* Drug: Sodium Chloride 9 mg/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Voluven (Hydroxyethyl starch 130/0,4)<br>Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) | Drug: Voluven (Hydroxyethyl starch 130/0,4)<br>* 7,5 ml/kg in the first hour and then 5 ml/kg<br>* Other names: Hydroxyethyl starch;|
| Placebo Comparator: Sodium Chloride 9 mg/ml<br>Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) | Drug: Sodium Chloride 9 mg/ml<br>* 7,5 ml/kg in the first hour and then 5 ml/kg<br>* Other names: Istone saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| u-Kim 1, u- FABP | 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 | 2-4 hours | 
| FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC | Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy | 2-4 hours | 
| PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot | Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy | 2-4 hours | 
| SBP, DBP, heartrate | Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy | 2-4 hours |