Hydroxyethyl Starch and Renal Function After Radical Prostatectomy

Prostate Cancer Clinical Trial

— VORA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486563
• Other study ID #: ASK-2-2011
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2011
• Last updated: September 16, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Voluven (Hydroxyethyl starch 130/0,4)
7,5 ml/kg in the first hour and then 5 ml/kg
• Sodium Chloride 9 mg/ml
7,5 ml/kg in the first hour and then 5 ml/kg

Locations

Country	Name	City	State
Denmark	Medicinsk forskningsafsnit, Regionshospitalet Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	FENa, u-ENaCß, CH2O, u-AQP2,u-NCC, u-NK2CC	Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective radical prostatectomy	2-4 hours	No
Secondary	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	No
Secondary	SBP, DBP, heartrate	Fourthly to measure the effect of hydroxyethyl starch on central hemodynamics during elective radical prostatectomy	2-4 hours	No