Condition category
Surgery
Date applied
19/10/2009
Date assigned
29/10/2009
Last edited
04/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eduard Kasal

ORCID ID

Contact details

Department of Anesthesia and Intensive Care
Charles University Teaching Hospital
Alej Svobody 80
Plzen
30460
Czech Republic

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 measures

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

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

http://www.fnplzen.cz/

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes