Hydroxyethyl Starch and Renal Function After Radical Prostatectomy (VORA)
This study has been completed.
Sponsor:
Regional Hospital Holstebro
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01486563
First received: December 4, 2011
Last updated: September 16, 2013
Last verified: September 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Voluven (Hydroxyethyl starch 130/0,4) Drug: Sodium Chloride 9 mg/ml |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy |
Resource links provided by NLM:
Further study details as provided by Regional Hospital Holstebro:
Primary Outcome Measures:
- u-NGAL [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- u-Kim 1, u- FABP [ Time Frame: 2-4 hours ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]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 [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective radical prostatectomy
- SBP, DBP, heartrate [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy
| Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Voluven (Hydroxyethyl starch 130/0,4)
Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
|
Drug: Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg
Other Names:
|
|
Placebo Comparator: Sodium Chloride 9 mg/ml
Patients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
|
Drug: Sodium Chloride 9 mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg
Other Name: Istone saline solution
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01486563
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486563
Locations
| Denmark | |
| Medicinsk forskningsafsnit, Regionshospitalet Holstebro | |
| Holstebro, Denmark, 7500 | |
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
| Principal Investigator: | Anne Sophie P. Kancir, MD PhD | Holstebro Regional Hospital |
More Information
No publications provided
| Responsible Party: | Erling Bjerregaard Pedersen, Professor, Regional Hospital Holstebro |
| ClinicalTrials.gov Identifier: | NCT01486563 History of Changes |
| Other Study ID Numbers: | ASK-2-2011 |
| Study First Received: | December 4, 2011 |
| Last Updated: | September 16, 2013 |
| Health Authority: | Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Hydroxyethyl Starch Derivatives Blood Substitutes Hematologic Agents |
Pharmacologic Actions Plasma Substitutes Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015