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Effect of Hydroxyethyl Starch on Renal Handling During Kidney Removal Surgery
NCT01486550Phase 4
Key facts
- Status
- Terminated
- Start
- Dec 2011
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- Regionshospitalet Holstebro
- Modality
- Polymer-based Nanoparticles, Lipid-based Nanoparticles, Small Molecules
- Drugs
- hetastarch
- Conditions
- hypovolemia
01
Overview
Phase 4, randomised trial of hetastarch in hypovolemia (2 arms), sponsored by Regionshospitalet Holstebro. Primary endpoint: Urine Neutrophil Gelatinase-Associated Lipocalin. Started Dec 2011; status: terminated.
02
Design
2 arms- Study design
- Randomized
Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg minimum
Sodium Chloride 9mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg
03
Who it enrols
Adult patients indicated for laparoscopic nephrectomy, excluding those who donated blood recently, have eGFR < 15ml/min, or are pregnant/breastfeeding.
04
Endpoints
Primary
Urine Neutrophil Gelatinase-Associated Lipocalin
Secondary
Urine Kidney Injury Molecule-1
Urine Liver-Type Fatty Acid-Binding Protein
Fractional Excretion of Sodium
Urine Epithelial Sodium Channel Beta Subunit
Free Water Clearance
Urine Aquaporin-2
Urine Sodium-Chloride Symporter
Urine Na-K-2Cl Cotransporter
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