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Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients
ISRCTN ISRCTN95085011
DOI 10.1186/ISRCTN95085011
ClinicalTrials.gov identifier
EudraCT number
Public title Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients
Scientific title Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients: a randomised prospective single-centre study
Acronym SVVOPT
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Local Research Ethics Committee of University Hospital in Plzen, approved on 14/06/2007
Study design Open randomised controlled trial
Countries of recruitment Czech Republic
Disease/condition/study domain Fluid optimisation of high risk surgical patients undergoing major abdominal surgery
Participants - inclusion criteria 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.
Participants - exclusion criteria 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
Anticipated start date 01/07/2007
Anticipated end date 30/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 120
Interventions 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.
Primary outcome measure(s) Postoperative morbidity based on occurrence (rate and number) of postoperative infectious and organ complications until 30 days after operation.
Secondary outcome measure(s) 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)
Sources of funding Ministry of Education (Czech Republic) (project ref: MSM0021620819)
Trial website
Publications 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
2014 economic evaluation results in: http://www.ncbi.nlm.nih.gov/pubmed/24891837
Contact name Prof  Eduard  Kasal
  Address Department of Anesthesia and Intensive Care
Charles University Teaching Hospital
Alej Svobody 80
  City/town Plzen
  Zip/Postcode 30460
  Country Czech Republic
Sponsor Charles University Teaching Hospital Plzen (Czech Republic)
  Address Department of Anesthesia and Intensive Care
Alej Svobody 80
  City/town Plzen
  Zip/Postcode 304 60
  Country Czech Republic
  Tel +420 377104381
  Email benesj@fnplzen.cz
  Sponsor website: http://www.fnplzen.cz/
Date applied 19/10/2009
Last edited 04/06/2014
Date ISRCTN assigned 29/10/2009
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