Intraoperative fluid optimisation using stroke volume variation in high risk surgical patients
| ISRCTN | ISRCTN95085011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95085011 |
| Protocol serial number | N/A |
| Sponsor | Charles University Teaching Hospital Plzen (Czech Republic) |
| Funder | Ministry of Education (Czech Republic) (project ref: MSM0021620819) |
- 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
Scientific
Department of Anesthesia and Intensive Care
Charles University Teaching Hospital
Alej Svobody 80
Plzen
30460
Czech Republic
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Postoperative morbidity based on occurrence (rate and number) of postoperative infectious and organ complications until 30 days after operation. |
| Key secondary outcome measure(s) |
1. Duration of hospital and intensive care unit (ICU) stay |
| Completion date | 30/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
30460
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2010 | 12/04/2021 | Yes | No | |
| Abstract results | 13/03/2009 | No | No | ||
| Other publications | economic evaluation results | 22/05/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
