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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01486563
First received: December 4, 2011
Last updated: September 16, 2013
Last verified: September 2013

December 4, 2011
September 16, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
u-NGAL [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01486563 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing 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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Prostate Cancer
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01486563
ASK-2-2011
Yes
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Anne Sophie P. Kancir, MD PhD Holstebro Regional Hospital
Regional Hospital Holstebro
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP