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NCT07917494Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
184 (estimated)
First submitted
29 Oct 2026
Start date
21 Sept 2026
Primary completion date
Sept 2029
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Diseases
Obesity
NCT number
NCT07917494

What you commit to

  • Study type: Interventional
  • Planned participants: 184
  • From 21 Sept 2026 to the primary completion date, Sept 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Surgery on the aortic arch
  • Emergency surgery

Other illness

  • Off-pump cardiac surgery
  • Heart transplantation or mechanical circulatory support surgery
  • Coexisting disease with a high probability of death within 6 months

Lab values

  • Advanced chronic kidney disease (renal clearance \< 30 ml/min)
  • Preoperative anemia (hemoglobin \< 10 g/dL)

Other

  • Minors
  • BMI \< 30 kg/m²
  • Planned perioperative hypothermia \< 32ºC
  • 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
  • Body surface area (actual body weight) \> 2.5 m²

Who the study is looking for

  • 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
  • Surgery on the aortic root (aortic tube, Bentall procedure, Tirone David, or others)
  • Combined surgery
  • Affiliation to a social security scheme
  • Written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chu Amiens Picardie
Coordinator of this site? Confirm its status
AmiensFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.