Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery (IDEALFLOW)
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Osama ABOU ARAB, Pr
- Telefonnummer: 33+3 22 08 78 36
- E-post: AbouArab.Osama@chu-amiens.fr
Studiesteder
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Amiens, Frankrike, 80054
- Rekruttering
- CHU Amiens Picardie
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Ta kontakt med:
- Osama ABOU ARAB, MD
- Telefonnummer: +33322087836
- E-post: abouarab.osama@chu-amiens.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Minors
- BMI < 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 (hemoglobin < 10 g/dL)
- Body surface area (actual body weight) > 2.5 m²
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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) |
CPB is standardized according to the following protocol:
Anticoagulation will be managed according to center practices to maintain an activated clotting time (ACT) > 400 seconds, in accordance with recommendations. |
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Aktiv komparator: 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. |
CPB is standardized according to the following protocol:
Anticoagulation will be managed according to center practices to maintain an activated clotting time (ACT) > 400 seconds, in accordance with recommendations. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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reduction in the incidence of erythrocyte concentrates transfused
Tidsramme: 1 day
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reduction in the incidence of erythrocyte concentrates transfused from the start to the end of cardiopulmonary bypass (CPB) |
1 day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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hematocrit measurement during CPB
Tidsramme: 1 day
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Hemodilution quantified by hematocrit measurement during CPB |
1 day
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Number of platelet concentrates administered during CPB
Tidsramme: 1 day
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Number of platelet concentrates administered during CPB |
1 day
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Number of fresh frozen plasma units administered during CPB
Tidsramme: 1 day
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Number of fresh frozen plasma units administered during CPB |
1 day
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Number of labile blood products administered during the entire ICU stay
Tidsramme: 1 day
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Number of labile blood products administered during the entire ICU stay |
1 day
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Number of Acute kidney injury
Tidsramme: within 7 days
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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 |
within 7 days
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PI2026_843_0111
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