- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486576
Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery (VOHO)
Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Hip Replacement Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Holstebro, Denmark, 7500
- Medicinsk forskningsafsnit, Regionshospitalet Holstebro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Voluven (Hydroxyethyl starch 130/0,4)
Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride.
Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
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7,5 ml/kg in the first hour and then 5 ml/kg
Other Names:
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PLACEBO_COMPARATOR: Sodium Chloride 9 mg/ml
Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride.
Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
|
7,5 ml/kg in the first hour and then 5 ml/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
u-NGAL
Time Frame: 2-4 hours
|
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
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2-4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
u-Kim1, u-LFABP
Time Frame: 2-4 hours
|
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
|
2-4 hours
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FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
Time Frame: 2-4 hours
|
Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water during elective hip replacement surgery
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2-4 hours
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PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
Time Frame: 2-4 hours
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Secondarily to measure the effect of hydroxyethyl starch on vasoactive hormones during elective hip replacement surgery
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2-4 hours
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SBP, DBP, heartrate
Time Frame: 2-4 hours
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Secondarily to measure the effect of hydroxyethyl starch on central hemodynamics during elective hip replacement surgery
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2-4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Sophie P. Kancir, MD PhD, Holstebo Regional Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASK-3-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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