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Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy (VONE)

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ClinicalTrials.gov Identifier: NCT01486550
Recruitment Status : Terminated (Lack of patient enrollment)
First Posted : December 6, 2011
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: Voluven (Hydroxyethyl starch 130/0,4) Drug: Sodium Chloride 9mg/ml Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Hydroxyethyl Starch on Renal Handling of Salt and Water, Blood Pressure-regulating Hormones, Proteins and Circulatory System of Patients Undergoing Kidney Removal by Keyhole Surgery
Study Start Date : December 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Voluven (Hydroxyethyl starch 130/0,4)
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Drug: Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg minimum
Other Names:
  • Voluven
  • Hydroxyethyl starch
  • Venofundin

Placebo Comparator: Sodium Chloride 9mg/ml
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Drug: Sodium Chloride 9mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg
Other Name: Isotone saline solution




Primary Outcome Measures :
  1. u-NGAL [ Time Frame: 2-4 hours ]
    The main objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity


Secondary Outcome Measures :
  1. u-Kim1 and u-LFABP [ Time Frame: 2-4 hours ]
    Another objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFAPB, 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 laparoscopic nephrectomy

  3. PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin [ Time Frame: 2-4 hours ]
    Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy

  4. SBP, DBP, heartrate [ Time Frame: 2-4 hours ]
    Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Males and females
  • Indication for laparoscopic nephrectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486550


Locations
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Denmark
Medicinck forskningsafsnit, Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
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Principal Investigator: Anne Sophie P. Kancir, MD PhD Regional Hospital Holstebro

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Responsible Party: Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01486550    
Other Study ID Numbers: ASK-1-2011
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes