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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Voluven (Hydroxyethyl starch 130/0,4)
Sodium Chloride 9 mg/ml
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medicinsk forskningsafsnit, Regionshospitalet Holstebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Voluven (Hydroxyethyl starch 130/0,4)

Sodium Chloride 9 mg/ml

Arm Description

Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
SBP, DBP, heartrate
Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy

Full Information

First Posted
December 4, 2011
Last Updated
September 16, 2013
Sponsor
Regional Hospital Holstebro
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1. Study Identification

Unique Protocol Identification Number
NCT01486563
Brief Title
Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
Acronym
VORA
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voluven (Hydroxyethyl starch 130/0,4)
Arm Type
Active Comparator
Arm Description
Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Arm Title
Sodium Chloride 9 mg/ml
Arm Type
Placebo Comparator
Arm Description
Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Intervention Type
Drug
Intervention Name(s)
Voluven (Hydroxyethyl starch 130/0,4)
Other Intervention Name(s)
Voluven, Venofundin, Hydroxyethyl starch
Intervention Description
7,5 ml/kg in the first hour and then 5 ml/kg
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 9 mg/ml
Other Intervention Name(s)
Istone saline solution
Intervention Description
7,5 ml/kg in the first hour and then 5 ml/kg
Primary Outcome Measure Information:
Title
u-NGAL
Description
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
Time Frame
2-4 hours
Secondary Outcome Measure Information:
Title
u-Kim 1, u- FABP
Description
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
Time Frame
2-4 hours
Title
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
Description
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy
Time Frame
2-4 hours
Title
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
Description
Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
Time Frame
2-4 hours
Title
SBP, DBP, heartrate
Description
Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy
Time Frame
2-4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Sophie P. Kancir, MD PhD
Organizational Affiliation
Holstebro Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicinsk forskningsafsnit, Regionshospitalet Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25627076
Citation
Kancir ASP, Johansen JK, Ekeloef NP, Pedersen EB. The effect of 6% hydroxyethyl starch 130/0.4 on renal function, arterial blood pressure, and vasoactive hormones during radical prostatectomy: a randomized controlled trial. Anesth Analg. 2015 Mar;120(3):608-618. doi: 10.1213/ANE.0000000000000596.
Results Reference
derived

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Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

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