Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients: a randomised prospective single-centre study
Acronym
SVVOPT
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.
Ethics approval
Local Research Ethics Committee of University Hospital in Plzen, approved on 14/06/2007
Study design
Open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fluid optimisation of high risk surgical patients undergoing major abdominal surgery
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Postoperative morbidity based on occurrence (rate and number) of postoperative infectious and organ complications until 30 days after operation.
Secondary outcome measures
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)
Overall trial start date
01/07/2007
Overall trial end date
30/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
30/05/2009
Locations
Countries of recruitment
Czech Republic
Trial participating centre
Department of Anesthesia and Intensive Care
Plzen
30460
Czech Republic
Sponsor information
Organisation
Charles University Teaching Hospital Plzen (Czech Republic)
Sponsor details
Department of Anesthesia and Intensive Care
Alej Svobody 80
Plzen
304 60
Czech Republic
+420 377104381
benesj@fnplzen.cz
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Ministry of Education (Czech Republic) (project ref: MSM0021620819)
Alternative name(s)
Ministry of Education of the Republic of Korea, MOE
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Economic evaluation results
Benes J, Zatloukal J, Simanova A, Chytra I, Kasal E, Cost analysis of the stroke volume variation guided perioperative hemodynamic optimization - an economic evaluation of the SVVOPT trial results., BMC Anesthesiol, 2014, 14, 40, doi: 10.1186/1471-2253-14-40.