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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 29, 2013
May 1, 2013
1.2 years
December 4, 2011
May 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
2-4 hours
Secondary Outcomes (4)
u-Kim1, u-LFABP
2-4 hours
FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC
2-4 hours
PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot
2-4 hours
SBP, DBP, heartrate
2-4 hours
Study Arms (2)
Voluven (Hydroxyethyl starch 130/0,4)
ACTIVE COMPARATORPatients 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.
Sodium Chloride 9 mg/ml
PLACEBO COMPARATORPatients 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.
Interventions
7,5 ml/kg in the first hour and then 5 ml/kg
7,5 ml/kg in the first hour and then 5 ml/kg
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Males and females
- Indication for Arthroplasty of hip
You may not qualify if:
- Blood donation within the last month
- Lack of wish to participate
- eGFR\< 15ml/min
- pregnancy or breast feeding
- Need of NSAID
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Holstebro, 7500, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Sophie P. Kancir, MD PhD
Holstebo Regional Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 4, 2011
First Posted
December 6, 2011
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 29, 2013
Record last verified: 2013-05