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Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy (VONE)

This study is currently recruiting participants.
Verified May 2013 by Regional Hospital Holstebro
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01486550
First received: December 4, 2011
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • u-NGAL [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
    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:
  • u-Kim1 and u-LFABP [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]
    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

  • 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 laparoscopic nephrectomy

  • PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
    Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy

  • SBP, DBP, heartrate [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
    Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486550

Contacts
Contact: Anne Sophie P. Kancir +45 7843 6586 annekanc@rm.dk

Locations
Denmark
Medicinck forskningsafsnit, Regionshospitalet Holstebro Recruiting
Holstebro, Denmark, 7500
Contact: Anne Sophie P. Kancir     +45 7843 6586     annekanc@rm.dk    
Principal Investigator: Anne Sophie P. Kancir            
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Anne Sophie P. Kancir, MD PhD Regional Hospital Holstebro
  More Information

No publications provided

Responsible Party: Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01486550     History of Changes
Other Study ID Numbers: ASK-1-2011
Study First Received: December 4, 2011
Last Updated: May 28, 2013
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Kidney Diseases
Urologic Diseases
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013