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RecruitingNCT07917494IDEALFLOWUpdated Nov 4, 2026

Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery

An interventional study of cardiopulmonary bypas and Anticoagulation in Cardiopulmonary Bypass and Obese Patients, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cardiopulmonary Bypass
  • Obese Patients

Keywords

  • cardiopulmonary bypass
  • obese patients
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged over 18 years
  • Patients with obesity ( > 30 kg/m²)
  • Scheduled cardiac surgery under cardiopulmonary bypass (CPB):
  • Coronary artery bypass grafting (CABG)
  • Aortic valve replacement
  • Mitral valve repair or replacement
  • Surgery on the aortic root (aortic tube, Bentall procedure, Tirone David, or others)
  • Combined surgery
  • Affiliation to a social security scheme
  • Written

Exclusion criteria

Exclusion Criteria:

  • Minors
  • \< 30 kg/m²
  • Off-pump cardiac surgery
  • Surgery on the aortic arch
  • Planned perioperative hypothermia \< 32ºC
  • Emergency surgery
  • 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 ( \< 10 g/dL)
  • Body surface area (actual body weight) > 2.5 m²
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
184 participants (estimated)

Study arms

  • Experimental
    body surface area (BSA) calculated from ideal body weight

    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)

    Procedure: cardiopulmonary bypas · Other: Anticoagulation

  • Active comparator
    BSA calculated from actual body weight.

    Cardiac surgery under CPB with CPB flow indexed at 2.4 ml/min/m², using BSA calculated from actual body weight.

    Procedure: cardiopulmonary bypas · Other: Anticoagulation

Interventions

  • Procedurecardiopulmonary bypas

    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.

  • OtherAnticoagulation

    Anticoagulation will be managed according to center practices to maintain an activated clotting time (ACT) \> 400 seconds, in accordance with recommendations.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day

Secondary outcomes

  1. hematocrit measurement during CPB

    Hemodilution quantified by hematocrit measurement during CPB

    Time frame: 1 day

  2. Number of platelet concentrates administered during CPB

    Number of platelet concentrates administered during CPB

    Time frame: 1 day

  3. Number of fresh frozen plasma units administered during CPB

    Number of fresh frozen plasma units administered during CPB

    Time frame: 1 day

  4. Number of labile blood products administered during the entire ICU stay

    Number of labile blood products administered during the entire ICU stay

    Time frame: 1 day

  5. 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

    Time frame: within 7 days

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07917494
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Sep 21, 2026
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Osama ABOU ARAB, Pr
Contact
AbouArab.Osama@chu-amiens.fr
33+3 22 08 78 36

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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