Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery

Regional Hospital Holstebro42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

Voluven (Hydroxyethyl starch 130/0,4)DRUG

7,5 ml/kg in the first hour and then 5 ml/kg

Sodium Chloride 9 mg/mlDRUG

7,5 ml/kg in the first hour and then 5 ml/kg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Males and females * Indication for Arthroplasty of hip Exclusion Criteria: * Blood donation within the last month * Lack of wish to participate * eGFR\< 15ml/min * pregnancy or breast feeding * Need of NSAID

Locations (1)

Medicinsk forskningsafsnit, Regionshospitalet Holstebro

Holstebro, Denmark

Outcomes

Primary Outcomes

u-NGAL

The main objective is for the trial (only patients undergoing elective hip replacement surgery) to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity

Time frame: 2-4 hours

Secondary Outcomes

u-Kim1, u-LFABP

Another objective of the trial (only patients undergoing elective hip replacement surgery) to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFABP, which are biomarkers of nephrotoxicity

Time frame: 2-4 hours

FENa, u-ENaCβ, 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 hip replacement surgery

Time frame: 2-4 hours

PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot

Secondarily to measure the effect of hydroxyethyl starch on vasoactive hormones during elective hip replacement surgery

Time frame: 2-4 hours

SBP, DBP, heartrate

Secondarily to measure the effect of hydroxyethyl starch on central hemodynamics during elective hip replacement surgery

Time frame: 2-4 hours

Data from ClinicalTrials.gov

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