Cardiopulmonary BypassIDEALFLOWNCT07917494
Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
A study testing cardiopulmonary bypas and Anticoagulation in people with Cardiopulmonary Bypass and Obese Patients, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Cardiopulmonary bypass (CPB) pump flow is typically calculated according to body surface area (BSA) derived from actual body weight and temperature, following the 2024 European guidelines recommending an indexed flow of 2.4 L/min/m². Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Obese Patients
- What is being tested?
- cardiopulmonary bypas and Anticoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Patients with obesity (BMI > 30 kg/m²)
- Scheduled cardiac surgery under cardiopulmonary bypass (CPB):
- Coronary artery bypass grafting (CABG)
- Aortic valve replacement
- Mitral valve repair or replacement
Show all 10Show fewer
- Surgery on the aortic root (aortic tube, Bentall procedure, Tirone David, or others)
- Combined surgery
- Affiliation to a social security scheme
- Written informed consent
Who cannot join
- Minors
- BMI < 30 kg/m²
- Off-pump cardiac surgery
- Surgery on the aortic arch
- Planned perioperative hypothermia < 32ºC
- Emergency surgery
Show all 15Show fewer
- Heart transplantation or mechanical circulatory support surgery
- Infectious endocarditis
- Participation in another clinical trial within the past 30 days
- Pregnant, parturient, or breastfeeding women
- Patients under guardianship, curatorship, or deprived of civil rights
- Advanced chronic kidney disease (renal clearance < 30 ml/min)
- Coexisting disease with a high probability of death within 6 months
- Preoperative anemia (hemoglobin < 10 g/dL)
- Body surface area (actual body weight) > 2.5 m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, 80054
Osama ABOU ARAB, MD, +33322087836, abouarab.osama@chu-amiens.fr
About this study
Cardiopulmonary bypass (CPB) pump flow is typically calculated according to body surface area (BSA) derived from actual body weight and temperature, following the 2024 European guidelines recommending an indexed flow of 2.4 L/min/m². However, in obese patients, using actual weight leads to a high BSA and thus elevated pump flow, increasing technical challenges such as the need for larger cannulas, higher circulating blood volume, and elevated pump speeds. These adjustments may increase risks of hemodilution, transfusion, and hemolysis. Given that lean body mass in obese patients is similar to that of non-obese patients of the same height-and that aerobic metabolism depends on lean mass-adjusting CPB flow based on ideal body weight rather than actual weight could reduce transfusions and associated complications. Several observational studies support the concept of using ideal body weight for CPB flow calculation in obese patients. Despite this, no randomized controlled trial has yet addressed the clinical impact of this approach. Given the increasing prevalence of obesity and the practical challenges it poses during cardiac surgery, a controlled clinical trial is warranted.
The investigators hypothesize that adjusting the cardiopulmonary bypass (CPB) flow according to the ideal body weight rather than the actual body weight in obese patients could reduce the need for blood transfusions and limit the associated complications.
- Conditions
- Cardiopulmonary Bypass, Obese Patients
- Being tested
- cardiopulmonary bypas, Anticoagulation
- Keywords
- cardiopulmonary bypass, obese patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary bypasProcedure or surgery
CPB is standardized according to the following protocol:
- Cardiac index at 2.4 ml/min/m²
- Mean arterial pressure during CPB between 50 and 80 mm Hg
- Central venous oxygen saturation > 65%
- Hematocrit > 25%
- DO₂ > 280 ml/min/m²
- VCO₂/DO₂ > 6 (VCO₂: CO₂ production) CPB will be performed under normothermia, with a temperature > 36°C.
AnticoagulationOther
Anticoagulation will be managed according to center practices to maintain an activated clotting time (ACT) > 400 seconds, in accordance with recommendations.
| Study group | Role | What they receive |
|---|---|---|
| body surface area (BSA) calculated from ideal body weight | Experimental | Cardiac surgery under cardiopulmonary bypass (CPB) with CPB flow indexed at 2.4 ml/min/m², using body surface area (BSA) calculated from ideal body weight (Lorentz formula) Receives: Procedure: cardiopulmonary bypas; Other: Anticoagulation |
| BSA calculated from actual body weight. | Active comparator | Cardiac surgery under CPB with CPB flow indexed at 2.4 ml/min/m², using BSA calculated from actual body weight. Receives: Procedure: cardiopulmonary bypas; Other: Anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the incidence of erythrocyte concentrates transfused
reduction in the incidence of erythrocyte concentrates transfused from the start to the end of cardiopulmonary bypass (CPB)
Measured: 1 day
Secondary outcomes (5)
hematocrit measurement during CPB
Hemodilution quantified by hematocrit measurement during CPB
Measured: 1 day
Number of platelet concentrates administered during CPB
Number of platelet concentrates administered during CPB
Measured: 1 day
Number of fresh frozen plasma units administered during CPB
Number of fresh frozen plasma units administered during CPB
Measured: 1 day
Number of labile blood products administered during the entire ICU stay
Number of labile blood products administered during the entire ICU stay
Measured: 1 day
Number of Acute kidney injury
Acute kidney injury defined according to KDIGO criteria by an increase in serum creatinine ≥26.5 μmol/L or at least 1.5 times the baseline value within 7 days after surgery compared to the preoperative baseline
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start21 Sep 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917494
- Sponsor's protocol ID
- PI2026_843_0111
- Acronym
- IDEALFLOW
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07917494
- Acronym / sponsor ID
- IDEALFLOW / PI2026_843_0111
- Conditions
- Cardiopulmonary Bypass, Obese Patients
- Keywords
- cardiopulmonary bypass, obese patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 Nov 2026 (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.
Cardiopulmonary bypass (CPB) pump flow is typically calculated according to body surface area (BSA) derived from actual body weight and temperature, following the 2024 European guidelines recommending an indexed flow of 2.4 L/min/m². However, in obese patients, using actual weight leads to a high BSA and thus elevated pump flow, increasing technical challenges such as the need for larger cannulas, higher circulating blood volume, and elevated pump speeds. These adjustments may increase risks of hemodilution, transfusion, and hemolysis. Given that lean body mass in obese patients is similar to that of non-obese patients of the same height-and that aerobic metabolism depends on lean mass-adjusting CPB flow based on ideal body weight rather than actual weight could reduce transfusions and associated complications. Several observational studies support the concept of using ideal body weight for CPB flow calculation in obese patients. Despite this, no randomized controlled trial has yet addressed the clinical impact of this approach. Given the increasing prevalence of obesity and the practical challenges it poses during cardiac surgery, a controlled clinical trial is warranted.
The investigators hypothesize that adjusting the cardiopulmonary bypass (CPB) flow according to the ideal body weight rather than the actual body weight in obese patients could reduce the need for blood transfusions and limit the associated complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| body surface area (BSA) calculated from ideal body weight | Experimental | Procedure: cardiopulmonary bypas, Other: AnticoagulationCardiac surgery under cardiopulmonary bypass (CPB) with CPB flow indexed at 2.4 ml/min/m², using body surface area (BSA) calculated from ideal body weight (Lorentz formula) |
| BSA calculated from actual body weight. | Active comparator | Procedure: cardiopulmonary bypas, Other: AnticoagulationCardiac surgery under CPB with CPB flow indexed at 2.4 ml/min/m², using BSA calculated from actual body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged over 18 years
- Patients with obesity (BMI > 30 kg/m²)
- Scheduled cardiac surgery under cardiopulmonary bypass (CPB):
- Coronary artery bypass grafting (CABG)
- Aortic valve replacement
Key exclusion criteria (15 listed)
- Minors
- BMI < 30 kg/m²
- Off-pump cardiac surgery
- Surgery on the aortic arch
- Planned perioperative hypothermia < 32ºC
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 bypasCPB is standardized according to the following protocol: * Cardiac index at 2.4 ml/min/m² * Mean arterial pressure during CPB between 50 and 80 mm Hg * Central venous oxygen saturation > 65% * Hematocrit > 25% * DO₂ > 280 ml/min/m² * VCO₂/DO₂ > 6 (VCO₂: CO₂ production) CPB will be performed under normothermia, with a temperature > 36°C. | Procedure or surgery | BSA calculated from actual body weight., body surface area (BSA) calculated from ideal body weight |
| AnticoagulationAnticoagulation will be managed according to center practices to maintain an activated clotting time (ACT) > 400 seconds, in accordance with recommendations. | Other | BSA calculated from actual body weight., body surface area (BSA) calculated from ideal body weight |
Primary outcome
reduction in the incidence of erythrocyte concentrates transfused
Time frame: 1 day
reduction in the incidence of erythrocyte concentrates transfused from the start to the end of cardiopulmonary bypass (CPB)
5 secondary outcomes
hematocrit measurement during CPB
Time frame: 1 day
Number of platelet concentrates administered during CPB
Time frame: 1 day
Number of fresh frozen plasma units administered during CPB
Time frame: 1 day
Number of labile blood products administered during the entire ICU stay
Time frame: 1 day
Number of Acute kidney injury
Time frame: within 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary bypas and Anticoagulation in people with Cardiopulmonary Bypass and Obese Patients, run by Centre Hospitalier Universitaire, Amiens 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama ABOU ARAB, Pr (33+3 22 08 78 36, AbouArab.Osama@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the incidence of erythrocyte concentrates transfused (time frame: 1 day). 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 4 Nov 2026.