Effect of hydroxyethyl starch on renal handling of salt and water, blood pressure-regulating hormones, proteins and circulatory system of patients undergoing prostate removal

Effect of hydroxyethyl starch on renal handling of sodium and water, vasoactive hormones,biomarkers and the circulatory system in patients undergoing radical prostatectomy - Hydroxyethyl starch and renal function after radical prostatectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004274-28-DK

Enrollment

Registered

2011-09-09

Start date

2011-09-21

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing radical prostatectomy in generel anesthesia MedDRA version: 14.1 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Voluven 60 mg/ml Product Name: Hydroxyethyl starch Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the place

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Age > 18 years - Males - Indication for radical prostatectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Blooddonation within the last month - Lack of wish to participate - eGFR< 15ml/min

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is for elective laparoscopic nephrectomy to measure the effect of hydroxyethyl starch on biomarkers of nephrotoxicity (U-Alb, u- NGAL, u-Kim 1, u-FABP) ;Secondary Objective: Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water (FENa, u-ENaCß, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoactive hormones (PRC, p-Ang-II, p -Aldo, p-ANP, P-GDP, p-AVP, p-Endot), central hemodynamics (SBP, DBP, heart rate) and on the glycocalyx layer of the endothelium (syndecan-1) during elective radical prostatectomy;Primary end point(s): u- NGAL	—

Measure

Time frame

Main Objective: The objective is for elective laparoscopic nephrectomy to measure the effect of hydroxyethyl starch on biomarkers of nephrotoxicity (U-Alb, u- NGAL, u-Kim 1, u-FABP) ;Secondary Objective: Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water (FENa, u-ENaCß, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoactive hormones (PRC, p-Ang-II, p -Aldo, p-ANP, P-GDP, p-AVP, p-Endot), central hemodynamics (SBP, DBP, heart rate) and on the glycocalyx layer of the endothelium (syndecan-1) during elective radical prostatectomy;Primary end point(s): u- NGAL

—

Secondary

Measure	Time frame
Secondary end point(s): PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot, CH2O, u-AQP2, FENa u- EnaCß, u-Alb, u-Kim 1, u-FABP, u-NCC, u-NK2CC, heart rate, SBP, DBP and Syndecan-1	—

Countries

Denmark

Contacts

Public ContactMedicinsk forskningsafsnit

Regionshospitalet Holstebro

annekanc@rm.dk+457843 6586

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026