Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery (VOHO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01486576
First received: December 4, 2011
Last updated: May 28, 2013
Last verified: May 2013

December 4, 2011
May 28, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
u-NGAL [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01486576 on ClinicalTrials.gov Archive Site
  • u-Kim1, u-LFABP [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
    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
  • 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 hip replacement surgery
  • PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
    Secondarily to measure the effect of hydroxyethyl starch on vasoactive hormones during elective hip replacement surgery
  • SBP, DBP, heartrate [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
    Secondarily to measure the effect of hydroxyethyl starch on central hemodynamics during elective hip replacement surgery
Same as current
Not Provided
Not Provided
 
Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery
Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing 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.

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: Treatment
Osteoarthritis
  • 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: Isotone saline solution
  • Active Comparator: Voluven (Hydroxyethyl starch 130/0,4)
    Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride. Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
    Intervention: Drug: Voluven (Hydroxyethyl starch 130/0,4)
  • Placebo Comparator: Sodium Chloride 9 mg/ml
    Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride. Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
    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
42
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01486576
ASK-3-2011
Yes
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Anne Sophie P. Kancir, MD PhD Holstebo Regional Hospital
Regional Hospital Holstebro
May 2013

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