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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voluven (Hydroxyethyl starch 130/0,4) | Active Comparator | Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) |
|
| Sodium Chloride 9 mg/ml | Placebo Comparator | Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voluven (Hydroxyethyl starch 130/0,4) | Drug | 7,5 ml/kg in the first hour and then 5 ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| u-NGAL | 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 | 2-4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| u-Kim 1, u- FABP | 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 | 2-4 hours |
| FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Sophie P. Kancir, MD PhD | Holstebro Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicinsk forskningsafsnit, Regionshospitalet Holstebro | Holstebro | 7500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25627076 | Derived | Kancir ASP, Johansen JK, Ekeloef NP, Pedersen EB. The effect of 6% hydroxyethyl starch 130/0.4 on renal function, arterial blood pressure, and vasoactive hormones during radical prostatectomy: a randomized controlled trial. Anesth Analg. 2015 Mar;120(3):608-618. doi: 10.1213/ANE.0000000000000596. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
| D006895 | Hydroxyethyl Starch Derivatives |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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| Sodium Chloride 9 mg/ml | Drug | 7,5 ml/kg in the first hour and then 5 ml/kg |
|
|
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy |
| 2-4 hours |
| PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot | Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy | 2-4 hours |
| SBP, DBP, heartrate | Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy | 2-4 hours |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011134 |
| Polysaccharides |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |