Cardiac FlowOCOSO2NCT03828565
Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow
A study testing ScvO2 Perioperative continue monitoring in people with Cardiac Flow, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (VF) because of a failure or an excess of filling is deleterious for the patient. Several studies have assessed the traditionnal VF based on the clinic and the VF guided by quantitative critereas. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiac Flow
- What is being tested?
- ScvO2 Perioperative continue monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >50 years old
- ASA score ≥ 2
- requiring a major intra-abdominal scheduled surgery
- lasting more than 90 min
- in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors
Who cannot join
- <18 years old
- Pregnant or brest feeding patients
- no consentement
- Unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock);
- rhythm disorders type ACFA early intervention;
- Palliative surgery, ASA 5;
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow : Multicentric Randomized Control in Single Blind Study
In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (VF) because of a failure or an excess of filling is deleterious for the patient. Several studies have assessed the traditionnal VF based on the clinic and the VF guided by quantitative critereas. Thus studies have showed a decrease of morbidity and duration of patients' stay whose the VF was guided even on the long term. So, formal recommandations of experts (FRE) on the perioperative filling strategy of the SFAR ( Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized its pursuite while the absence of an increase of the ESV after a filling test signifies the useless and deleterious character of this one. The optimization of perioperative hemodynamics consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz: limit of its application to the routine. The central venous oxygen saturation (ScvO2) is simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The industry has developed continuous monitoring systems by reflection spectrophotometry using optical fibers installed in the central venous pathways. In daily practice, the stricto sensu application of FRE leads to administering an VF up to the limit of the preload dependence without evaluating the adequacy of the cardiac output, which is not a physiological situation. This filling is therefore sometimes performed solely on the criteria of preload dependence while it is potentially deleterious for the patient. No study has compared a strategy based on the use of ScvO2 and preload dependence with current recommendations based solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2 in the superior cave territory in intraoperative would allow to detect the patients with an inadequacy of the cardiac output and thus to select the only ones requiring a vascular filling. This would reduce postoperative complications related to overfilling, without exposing the patient to episodes of tissue hypoperfusion.
- Conditions
- Cardiac Flow
- Being tested
- ScvO2 Perioperative continue monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScvO2 Perioperative continue monitoringProcedure or surgery
ScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective> 8g / dL), SaO2 (objective> 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV> 13%, norepinephrine if PPV<9%, reassess if PPV between 9 and 13%.
If VF or norepinephrine does not correct ScvO2 (> 65%), a measurement of arterial lactate is performed. If lactatemia is> 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is <2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary.
| Study group | Role | What they receive |
|---|---|---|
| ScvO2 group | Active comparator | ScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%) Receives: Procedure: ScvO2 Perioperative continue monitoring |
| Control group | No intervention | End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.
CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Mar 2019
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac FlowStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier Arnaud, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828565
- Sponsor's protocol ID
- 2018-37
- Other IDs
- IDRCB
- Acronym
- OCOSO2
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pastene B, Bernat M, Baumstark K, Bezulier K, Gricourt Y, De Guibert JM, Charvet A, Colin M, Leone M, Zieleskiewicz L. OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery. Trials. 2023 Oct 11;24(1):659. doi: 10.1186/s13063-023-07689-z.
PubMed 37821968
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow : Multicentric Randomized Control in Single Blind Study
- ClinicalTrials.gov ID
- NCT03828565
- Acronym / sponsor ID
- OCOSO2 / 2018-37
- Conditions
- Cardiac Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (VF) because of a failure or an excess of filling is deleterious for the patient. Several studies have assessed the traditionnal VF based on the clinic and the VF guided by quantitative critereas. Thus studies have showed a decrease of morbidity and duration of patients' stay whose the VF was guided even on the long term. So, formal recommandations of experts (FRE) on the perioperative filling strategy of the SFAR ( Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized its pursuite while the absence of an increase of the ESV after a filling test signifies the useless and deleterious character of this one. The optimization of perioperative hemodynamics consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz: limit of its application to the routine. The central venous oxygen saturation (ScvO2) is simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The industry has developed continuous monitoring systems by reflection spectrophotometry using optical fibers installed in the central venous pathways. In daily practice, the stricto sensu application of FRE leads to administering an VF up to the limit of the preload dependence without evaluating the adequacy of the cardiac output, which is not a physiological situation. This filling is therefore sometimes performed solely on the criteria of preload dependence while it is potentially deleterious for the patient. No study has compared a strategy based on the use of ScvO2 and preload dependence with current recommendations based solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2 in the superior cave territory in intraoperative would allow to detect the patients with an inadequacy of the cardiac output and thus to select the only ones requiring a vascular filling. This would reduce postoperative complications related to overfilling, without exposing the patient to episodes of tissue hypoperfusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScvO2 group | Active comparator | Procedure: ScvO2 Perioperative continue monitoringScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%) |
| Control group | No intervention | –End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >50 years old
- ASA score ≥ 2
- requiring a major intra-abdominal scheduled surgery
- lasting more than 90 min
- in the visceral surgery, vascular surgery, urological surgery and gynecological surgery sectors
Key exclusion criteria (7 listed)
- <18 years old
- Pregnant or brest feeding patients
- no consentement
- Unstable acute pathology at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock);
- rhythm disorders type ACFA early intervention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScvO2 Perioperative continue monitoringScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective> 8g / dL), SaO2 (objective> 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV> 13%, norepinephrine if PPV<9%, reassess if PPV between 9 and 13%. If VF or norepinephrine does not correct ScvO2 (> 65%), a measurement of arterial lactate is performed. If lactatemia is> 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is <2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary. | Procedure or surgery | ScvO2 group |
Primary outcome
Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.
Time frame: Day 5
CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 37821968Pastene B, Bernat M, Baumstark K, Bezulier K, Gricourt Y, De Guibert JM, Charvet A, Colin M, Leone M, Zieleskiewicz L. OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery. Trials. 2023 Oct 11;24(1):659. doi: 10.1186/s13063-023-07689-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier Arnaud study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ScvO2 Perioperative continue monitoring in people with Cardiac Flow, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group. (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.