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ISRCTN
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ISRCTN95085011
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ClinicalTrials.gov identifier
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Public title
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Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients
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Scientific title
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Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients: a randomised prospective single-centre study
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Acronym
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SVVOPT
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Serial number at source
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N/A
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Study hypothesis
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Stroke volume variation guided fluid optimisation during major abdominal surgery in comparison with standard haemodynamic management may reduce organ dysfunction development and postoperative morbidity in high risk surgical patients.
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Lay summary
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Ethics approval
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Local Research Ethics Committee of University Hospital in Plzen, approved on 14/06/2007
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Study design
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Open randomised controlled trial
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Countries of recruitment
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Czech Republic
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Disease/condition/study domain
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Fluid optimisation of high risk surgical patients undergoing major abdominal surgery
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Participants - inclusion criteria
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High risk surgical patients of both gender scheduled for intraabdominal surgery with presumed blood loss of more than 1,000 ml or longer than 120 minutes with open peritoneal cavity.
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Participants - exclusion criteria
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1. Patients aged less than 18 years
2. Patients with irregular heart rhythm
3. Those with body weight less than 55 kg or more than 140 kg
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Anticipated start date
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01/07/2007
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Anticipated end date
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30/05/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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Patients were randomised into protocol or control group using sealed envelopes method.
Fluid management in control group patients was managed using routine cardiovascular and clinical monitoring.
Haemodynamic optimisation of protocol group patients was provided with colloid boluses of 3 ml/kg guided by stroke volume variation and other haemodynamic variables according to the protocol based on data obtained by Vigileo™/FloTrac™ monitor.
After operation fluid management and overall postoperative care was the same in both groups.
Patients were followed at least 30 days after operation, if hospitalised at this day then till hospital discharge.
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Primary outcome measure(s)
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Postoperative morbidity based on occurrence (rate and number) of postoperative infectious and organ complications until 30 days after operation.
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Secondary outcome measure(s)
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1. Duration of hospital and intensive care unit (ICU) stay
2. All cause mortality
3. Biochemical parameters of oxygen debt during operation and in early postoperative period (8 hours)
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Sources of funding
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Ministry of Education (Czech Republic) (project ref: MSM0021620819)
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Trial website
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Publications
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Poster presentation of the preliminary results, 29th International Symposium on Intensive Care and Emergency Medicine, Brussels, Belgium. 24-27 March 2009
http://ccforum.com/content/13/S1/P201
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Contact name
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Prof
Eduard
Kasal
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Address
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Department of Anesthesia and Intensive Care
Charles University Teaching Hospital
Alej Svobody 80
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City/town
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Plzen
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Zip/Postcode
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30460
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Country
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Czech Republic
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Sponsor
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Charles University Teaching Hospital Plzen (Czech Republic)
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Address
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Department of Anesthesia and Intensive Care
Alej Svobody 80
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City/town
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Plzen
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Zip/Postcode
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304 60
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Country
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Czech Republic
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Tel
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+420 377104381
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Email
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benesj@fnplzen.cz
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Sponsor website:
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http://www.fnplzen.cz/
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Date applied
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19/10/2009
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Last edited
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29/10/2009
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Date ISRCTN assigned
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29/10/2009
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