Cardiac SurgeryOPTI-DO2NCT05984563
Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass
An observational study of Cardiac Surgery, run by University Hospital, Lille at 1 site in France.
Trial summary
Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Cardiopulmonary bypass
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2023to 19 Nov 2023
- Phase
- Observational
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery under CPB at the university hospital of Lille, France
Who may be able to join
- Patients aged over 18
- Patients scheduled for elective cardiac surgery under CPB at the university hospital of Lille, France
- Patients with given written consent
- Patient insured under the French social security system
Who cannot join
- Pregnant or breastfeeding
- Off pump cardiac surgery
- Lack of DO2 monitoring
- Emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, LVAD implantation) Uncontrolled sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass
Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.
- Conditions
- Cardiac Surgery
- Being tested
- Cardiopulmonary bypass
- Keywords
- Oxygen delivery, Cardiopulmonary bypass, Cardiac surgery, Goal-directed perfusion, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary bypassDevice
CPB will be ensured as usual care: priming volume will be set as 1200 to 1500 mL. Patient blood management and hemodynamic management will be left at the discretion of the anesthesiologist in charge of the patient. Anticoagulation during CPB will be handled through an initial heparin bolus of 300-400 UI/kg followed by additional boluses to maintain ACT above 400 s. Non-heparin-coated bypass circuits incorporating an integrated phosphorylcholine-coated oxygenation system will be used.
What is being measured
The primary outcome is the main question the study is designed to answer.
values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)
Measured: Every 20 to 30 seconds during CPB (standard care) and up to 28 days
Secondary outcomes (3)
Incidence of postoperative AKI using creatinine measurement (standard care)
Measured: up to 48 hours postoperative
Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores
Measured: up to 48 hours postoperative
Vital status checklist
Measured: up to 28 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start3 Oct 2023
- Primary completion19 Nov 2023
- Study completion19 Nov 2023
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984563
- Sponsor's protocol ID
- 2022_0705
- Acronym
- OPTI-DO2
- Status last verified
- May 2026
- First submitted
- 31 Jul 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05984563
- Acronym / sponsor ID
- OPTI-DO2 / 2022_0705
- Conditions
- Cardiac Surgery
- Keywords
- Oxygen delivery, Cardiopulmonary bypass, Cardiac surgery, Goal-directed perfusion, Acute kidney injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 9 Aug 2023 (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.
Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery under CPB at the university hospital of Lille, France
Key inclusion criteria (4 listed)
- Patients aged over 18
- Patients scheduled for elective cardiac surgery under CPB at the university hospital of Lille, France
- Patients with given written consent
- Patient insured under the French social security system
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Off pump cardiac surgery
- Lack of DO2 monitoring
- Emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, LVAD implantation) Uncontrolled sepsis
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 |
|---|---|---|
| Cardiopulmonary bypassCPB will be ensured as usual care: priming volume will be set as 1200 to 1500 mL. Patient blood management and hemodynamic management will be left at the discretion of the anesthesiologist in charge of the patient. Anticoagulation during CPB will be handled through an initial heparin bolus of 300-400 UI/kg followed by additional boluses to maintain ACT above 400 s. Non-heparin-coated bypass circuits incorporating an integrated phosphorylcholine-coated oxygenation system will be used. | Device | – |
Primary outcome
values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)
Time frame: Every 20 to 30 seconds during CPB (standard care) and up to 28 days
3 secondary outcomes
Incidence of postoperative AKI using creatinine measurement (standard care)
Time frame: up to 48 hours postoperative
Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores
Time frame: up to 48 hours postoperative
Vital status checklist
Time frame: up to 28 days postoperative
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by University Hospital, Lille 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 May 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.
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?
values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care) (time frame: Every 20 to 30 seconds during CPB (standard care) and up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.