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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Osama ABOU ARAB, Pr
- 電話番号：33+3 22 08 78 36
- メール：AbouArab.Osama@chu-amiens.fr
研究場所
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Amiens、フランス、80054
- 募集
- CHU Amiens Picardie
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コンタクト：
- Osama ABOU ARAB, MD
- 電話番号：+33322087836
- メール：abouarab.osama@chu-amiens.fr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
reduction in the incidence of erythrocyte concentrates transfused
時間枠：1 day
|
reduction in the incidence of erythrocyte concentrates transfused from the start to the end of cardiopulmonary bypass (CPB) |
1 day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
hematocrit measurement during CPB
時間枠：1 day
|
Hemodilution quantified by hematocrit measurement during CPB |
1 day
|
|
Number of platelet concentrates administered during CPB
時間枠：1 day
|
Number of platelet concentrates administered during CPB |
1 day
|
|
Number of fresh frozen plasma units administered during CPB
時間枠：1 day
|
Number of fresh frozen plasma units administered during CPB |
1 day
|
|
Number of labile blood products administered during the entire ICU stay
時間枠：1 day
|
Number of labile blood products administered during the entire ICU stay |
1 day
|
|
Number of Acute kidney injury
時間枠：within 7 days
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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