Hydroxyethyl Starch and Renal Function After Laparoscopic Nephrectomy

Phase 4

Terminated

• Conditions: Kidney Cancer
• Interventions: Drug: Sodium Chloride 9mg/ml; Drug: Voluven (Hydroxyethyl starch 130/0,4)

• Registration Number: NCT01486550
• Lead Sponsor: Regional Hospital Holstebro

Brief 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.

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Age > 18 years
• Males and females
• Indication for laparoscopic nephrectomy

Exclusion Criteria

• Blood donation within the last month
• Lack of wish to participate
• eGFR< 15ml/min
• Pregnancy or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride 9mg/ml	Sodium Chloride 9mg/ml	Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Voluven (Hydroxyethyl starch 130/0,4)	Voluven (Hydroxyethyl starch 130/0,4)	Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

Primary Outcome Measures

Name	Time	Method
u-NGAL	2-4 hours	The main objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity

Secondary Outcome Measures

Name	Time	Method
u-Kim1 and u-LFABP	2-4 hours	Another objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-Kim1 and u-LFAPB, which are also biomarkers of nephrotoxicity
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC	2-4 hours	Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective laparoscopic nephrectomy
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin	2-4 hours	Thirdly to measure the effect of hydroxyethyl starch on vasoactive hormones during elective laparoscopic nephrectomy
SBP, DBP, heartrate	2-4 hours	Fourthly measure the effect of hydroxyethyl starch on central hemodynamics during elective laparoscopic nephrectomy

Trial Locations

Locations (1)

Medicinck forskningsafsnit, Regionshospitalet Holstebro; 🇩🇰 Holstebro, Denmark