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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01486563
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Voluven (Hydroxyethyl starch 130/0,4) Drug: Sodium Chloride 9 mg/ml Phase 4

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 Design

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
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)
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
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. SBP, DBP, heartrate [ Time Frame: 2-4 hours ]
    Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy


Eligibility Criteria

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

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Denmark
Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Anne Sophie P. Kancir, MD PhD Holstebro Regional Hospital
More Information

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