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NCT Number: NCT01486563

Hydroxyethyl Starch and Renal Function After 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medicinsk forskningsafsnit, Regionshospitalet Holstebro

Holstebro, 7500, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voluven (Hydroxyethyl starch 130/0,4)

Drug

7,5 ml/kg in the first hour and then 5 ml/kg

Other names: Voluven, Venofundin, Hydroxyethyl starch

Sodium Chloride 9 mg/ml

Drug

7,5 ml/kg in the first hour and then 5 ml/kg

Other names: Istone saline solution

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy

Acronym: VORA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2011
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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