Prostate Cancer
Conditions
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
Interventions
7,5 ml/kg in the first hour and then 5 ml/kg
7,5 ml/kg in the first hour and then 5 ml/kg
Sponsors
Regional Hospital Holstebro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Males * Indication for radical prostatectomy
Exclusion criteria
* Blood donation within the last month * Lack of wish to participate * eGFR\< 15ml/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| u-NGAL | 2-4 hours | The main objective for the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| u-Kim 1, u- FABP | 2-4 hours | Another objective of the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFABP, which are also biomarkers of nephrotoxicity |
| FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC | 2-4 hours | Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy |
| PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot | 2-4 hours | Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy |
| SBP, DBP, heartrate | 2-4 hours | Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy |
Countries
Denmark
Outcome results
None listed