Hydroxyethyl Starch and Renal Function After Radical Prostatectomy
VORA
Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Radical Prostatectomy
1 other identifier
interventional
40
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 below P25 for phase_4 prostate-cancer
Started Jan 2012
Shorter than P25 for phase_4 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedSeptember 17, 2013
September 1, 2013
1.4 years
December 4, 2011
September 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
u-NGAL
The main objective for the trial (only patients undergoing elective radical prostatectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity
2-4 hours
Secondary Outcomes (4)
u-Kim 1, u- FABP
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 radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
Sodium Chloride 9 mg/ml
PLACEBO COMPARATORPatients undergoing radical prostatectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)
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
- Indication for radical prostatectomy
You may not qualify if:
- Blood donation within the last month
- Lack of wish to participate
- eGFR\< 15ml/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicinsk forskningsafsnit, Regionshospitalet Holstebro
Holstebro, 7500, Denmark
Related Publications (1)
Kancir ASP, Johansen JK, Ekeloef NP, Pedersen EB. The effect of 6% hydroxyethyl starch 130/0.4 on renal function, arterial blood pressure, and vasoactive hormones during radical prostatectomy: a randomized controlled trial. Anesth Analg. 2015 Mar;120(3):608-618. doi: 10.1213/ANE.0000000000000596.
PMID: 25627076DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Sophie P. Kancir, MD PhD
Holstebro Regional Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- 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
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 17, 2013
Record last verified: 2013-09