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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

This study is currently recruiting participants.
Verified June 2012 by Regional Hospital Holstebro
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01486563
First received: December 4, 2011
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: Voluven 60 mg/ml
Drug: Sodium Chloride 9 mg/ml
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 60 mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg
Other Names:
  • Voluven
  • Venofundin
  • Hydroxyethyl starch
Placebo Comparator: Sodium Chloride
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486563

Contacts
Contact: Anne Sophie P. Kancir +45 7843 6586 annekanc@rm.dk

Locations
Denmark
Medicinsk forskningsafsnit, Regionshospitalet Holstebro Recruiting
Holstebro, Denmark, 7500
Contact: Anne Sophie P. Kancir     +45 7843 6586     annekanc@rm.dk    
Principal Investigator: Anne Sophie P. Kancir            
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Anne Sophie P. Kancir, MD PhD Holstebro Regional Hospital
  More Information

No publications provided

Responsible Party: Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01486563     History of Changes
Other Study ID Numbers: ASK-2-2011
Study First Received: December 4, 2011
Last Updated: June 13, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013