Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial

Richard Descamps , Julien Amour (1) , Emmanuel Besnier (2, 3) , Adrien Bougle (1) , Hélène Charbonneau (4) , Martin Charvin (5) , Bernard Cholley (6, 7) , Olivier Desebbe (8) , Jean-Luc Fellahi (9, 10) , Denis Frasca (11, 12) , François Labaste (13, 14) , Diane Lena , Yazine Mahjoub (15, 16) , Paul-Michel Mertes (17) , Serge Molliex (18) , Pierre-Henry Mouri , Mouhamed Djahoum Moussa (19) , Jean-Ferreol Oilleau (20) , Alexandre Ouattara (21, 22) , Sophie Provenchere (23) , Bertand Rozec , Jean-Jacques Parienti , Marc-Olivier Fischer

1 CHU Pitié-Salpêtrière [AP-HP]
2 CHU Rouen
3 EnVI - Endothélium, valvulopathies et insuffisance cardiaque
4 Clinique Pasteur [Toulouse]
5 Pôle de Médecine Périopératoire [CHU Clermont-Ferrand]
6 IThEM - U1140 - Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis
7 HEGP - Hôpital Européen Georges Pompidou [APHP]
8 Clinique de la Sauvegarde [Lyon]
9 Hôpital Louis Pradel [CHU - HCL]
10 CarMeN - Cardiovasculaire, métabolisme, diabétologie et nutrition
11 SPHERE - MethodS in Patients-centered outcomes and HEalth ResEarch
12 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
13 Franco-czech Laboratory for clinical research on obesity
14 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
15 CHU Amiens-Picardie
16 SSPC - Simplification des soins chez les patients complexes - UR UPJV 7518
17 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
18 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
19 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
20 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
21 Biologie des maladies cardiovasculaires = Biology of Cardiovascular Diseases
22 CHU Bordeaux
23 Service d'anesthésie - réanimation chirurgicale [CHU Bichat]

Background: Postoperative morbidity and mortality after cardiac surgery with cardiopulmonary bypass (CPB) remain high despite recent advances in both anesthesia and perioperative management. Among modifiable risk factors for postoperative complications, optimal arterial pressure during and after surgery has been under debate for years. Recent data suggest that optimizing arterial pressure to the baseline of the patient may improve outcomes. We hypothesize that optimizing the mean arterial pressure (MAP) to the baseline MAP of the patient during cardiac surgery with CPB and during the first 24 hours postoperatively may improve outcomes. Study design: The OPTIPAM trial (NCT05403697) will be a multicenter, randomized, open-label controlled trial testing the superiority of optimized MAP management as compared with a MAP of 65mmHg or more during both the intraoperative and postoperative periods in 1100 patients scheduled for cardiac surgery with CPB. The primary composite end point is the occurrence of acute kidney injury, neurological complications including stroke or postoperative delirium, and death. The secondary endpoints are hospital and intensive care unit lengths of stay, Day 7 and Day 90 mortality, postoperative cognitive dysfunction on Day 7 and Day 90, and quality of life at Day 7 and Day 90. An interim analysis will assess the safety of the intervention. Conclusion: The OPTIPAM trial will assess the effectiveness of an individualized target of mean arterial pressure in cardiac surgery with CPB in reducing postoperative morbidity.

Mots clés: Arterial pressure; Cardiac surgery; Hemodynamic optimization

Domaines: Médecine humaine et pathologie

Richard Descamps, Julien Amour, Emmanuel Besnier, Adrien Bougle, Hélène Charbonneau, et al.. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. American Heart Journal, 2023, ⟨10.1016/j.ahj.2023.03.005⟩. ⟨hal-04044174⟩