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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004906-12-DK

Enrollment

Registered

2011-10-26

Start date

2011-11-07

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Patients undergoing hip replacement in spinal anesthesia MedDRA version: 14.0 Level: LLT Classification code 10003397 Term: Arthroplasty of hip System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Voluven 60 mg/ml Product Name: Hydroxyethyl starch Pharmaceutical Form: Solution for infusion Other descriptive name: STARCH Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years - Males and females - Indication for Arthroplasty of hip 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 - pregnancy or breast feeding - Need of NSAID

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) ;Primary end point(s): u- NGAL;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) and central hemodynamics (SBP, DBP, heart rate) during elective hip replacement surgery	—

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) ;Primary end point(s): u- NGAL;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) and central hemodynamics (SBP, DBP, heart rate) during elective hip replacement surgery

—

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 and DBP	—

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