Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients

ISRCTN	ISRCTN95085011
DOI	https://doi.org/10.1186/ISRCTN95085011
Secondary identifying numbers	N/A

Submission date: 19/10/2009
Registration date: 29/10/2009
Last edited: 12/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eduard Kasal
Scientific

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

Study information

Study design	Open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients: a randomised prospective single-centre study
Study acronym	SVVOPT
Study objectives	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(s)	Local Research Ethics Committee of University Hospital in Plzen, approved on 14/06/2007
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2007
Completion date	30/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	120
Total final enrolment	120
Key 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.
Key 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
Date of first enrolment	01/07/2007
Date of final enrolment	30/05/2009

Locations

Countries of recruitment

Czech Republic

Study participating centre

Department of Anesthesia and Intensive Care

Plzen
30460
Czech Republic

Sponsor information

Charles University Teaching Hospital Plzen (Czech Republic)
Hospital/treatment centre

Department of Anesthesia and Intensive Care
Alej Svobody 80
Plzen
304 60
Czech Republic

Phone	+420 377104381
Email	benesj@fnplzen.cz
Website	http://www.fnplzen.cz/
"ROR"	https://ror.org/024d6js02

Funders

Funder type

Government

Ministry of Education (Czech Republic) (project ref: MSM0021620819)
Government organisation / National government

Alternative name(s): Ministry of Education of the Republic of Korea, 교육부, MOE
Location: Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		13/03/2009		No	No
Other publications	economic evaluation results	22/05/2014		Yes	No
Results article		01/01/2010	12/04/2021	Yes	No

Editorial Notes

12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.