Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)
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ClinicalTrials.gov Identifier: NCT01486563 |
Recruitment Status
:
Completed
First Posted
: December 6, 2011
Last Update Posted
: September 17, 2013
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: Voluven (Hydroxyethyl starch 130/0,4) Drug: Sodium Chloride 9 mg/ml | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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)
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Drug: Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg
Other Names:
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Placebo Comparator: Sodium Chloride 9 mg/ml
Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
|
Drug: Sodium Chloride 9 mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg
Other Name: Istone saline solution
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- u-NGAL [ Time Frame: 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
- u-Kim 1, u- FABP [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2-4 hours ]Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
- SBP, DBP, heartrate [ Time Frame: 2-4 hours ]Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486563
Denmark | |
Medicinsk forskningsafsnit, Regionshospitalet Holstebro | |
Holstebro, Denmark, 7500 |
Principal Investigator: | Anne Sophie P. Kancir, MD PhD | Holstebro Regional Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro |
ClinicalTrials.gov Identifier: | NCT01486563 History of Changes |
Other Study ID Numbers: |
ASK-2-2011 |
First Posted: | December 6, 2011 Key Record Dates |
Last Update Posted: | September 17, 2013 |
Last Verified: | September 2013 |
Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives Plasma Substitutes Blood Substitutes |