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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- u-NGAL
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Voluven (Hydroxyethyl starch 130/0,4)
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Intervention: Voluven (Hydroxyethyl starch 130/0,4) (Drug)
Sodium Chloride 9mg/ml
Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Intervention: Sodium Chloride 9mg/ml (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC(2-4 hours)
- u-Kim1 and u-LFABP(2-4 hours)
- PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin(2-4 hours)
- SBP, DBP, heartrate(2-4 hours)
Investigators
Erling Bjerregaard Pedersen
Professor
Regional Hospital Holstebro