search
Back to results

Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy (VONE)

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Voluven (Hydroxyethyl starch 130/0,4)
Sodium Chloride 9mg/ml
Sponsored by
Regional Hospital Holstebro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medicinck forskningsafsnit, Regionshospitalet Holstebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Voluven (Hydroxyethyl starch 130/0,4)

Sodium Chloride 9mg/ml

Arm Description

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Outcomes

Primary Outcome Measures

u-NGAL
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
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
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
Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy
SBP, DBP, heartrate
Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy

Full Information

First Posted
December 4, 2011
Last Updated
October 8, 2014
Sponsor
Regional Hospital Holstebro
search

1. Study Identification

Unique Protocol Identification Number
NCT01486550
Brief Title
Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy
Acronym
VONE
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient enrollment
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voluven (Hydroxyethyl starch 130/0,4)
Arm Type
Active Comparator
Arm Description
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Arm Title
Sodium Chloride 9mg/ml
Arm Type
Placebo Comparator
Arm Description
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Intervention Type
Drug
Intervention Name(s)
Voluven (Hydroxyethyl starch 130/0,4)
Other Intervention Name(s)
Voluven, Hydroxyethyl starch, Venofundin
Intervention Description
7,5 ml/kg in the first hour and then 5 ml/kg minimum
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 9mg/ml
Other Intervention Name(s)
Isotone saline solution
Intervention Description
7,5 ml/kg in the first hour and then 5 ml/kg
Primary Outcome Measure Information:
Title
u-NGAL
Description
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
Time Frame
2-4 hours
Secondary Outcome Measure Information:
Title
u-Kim1 and u-LFABP
Description
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
Time Frame
2-4 hours
Title
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
Description
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective laparoscopic nephrectomy
Time Frame
2-4 hours
Title
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin
Description
Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy
Time Frame
2-4 hours
Title
SBP, DBP, heartrate
Description
Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy
Time Frame
2-4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Sophie P. Kancir, MD PhD
Organizational Affiliation
Regional Hospital Holstebro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicinck forskningsafsnit, Regionshospitalet Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy

We'll reach out to this number within 24 hrs