Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2014

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

Interventions

  • Drug: Voluven (Hydroxyethyl starch 130/0,4)
    • 7,5 ml/kg in the first hour and then 5 ml/kg minimum
  • Drug: Sodium Chloride 9mg/ml
    • 7,5 ml/kg in the first hour and then 5 ml/kg

Arms, Groups and Cohorts

  • 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)
  • Placebo Comparator: Sodium Chloride 9mg/ml
    • Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regional Hospital Holstebro
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erling Bjerregaard Pedersen, Professor – Regional Hospital Holstebro
  • Overall Official(s)
    • Anne Sophie P. Kancir, MD PhD, Principal Investigator, Regional Hospital Holstebro

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