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Completed

NCT Number: NCT01486576

Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery

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

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

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 and females
  • Indication for Arthroplasty of hip

Exclusion criteria

  • Blood donation within the last month
  • Lack of wish to participate
  • eGFR< 15ml/min
  • pregnancy or breast feeding
  • Need of NSAID

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: Isotone saline solution

Primary outcomes

  1. u-NGAL

    Time frame: 2-4 hours

    The main objective is for the trial (only patients undergoing elective hip replacement surgery) to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity

Secondary outcomes

  1. u-Kim1, u-LFABP

    Time frame: 2-4 hours

    Another objective of the trial (only patients undergoing elective hip replacement surgery) to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFABP, which are 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 hip replacement surgery

  3. PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot

    Time frame: 2-4 hours

    Secondarily to measure the effect of hydroxyethyl starch on vasoactive hormones during elective hip replacement surgery

  4. SBP, DBP, heartrate

    Time frame: 2-4 hours

    Secondarily to measure the effect of hydroxyethyl starch on central hemodynamics during elective hip replacement surgery

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 Hip Replacement Surgery

Acronym: VOHO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2011
Registry last updated
May 29, 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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