Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial - 22/05/23

Doi : 10.1016/j.ahj.2023.03.005

Richard Descamps, MD ^a,^⁎ , Julien Amour, MD, PhD ^b, Emmanuel Besnier, MD, PhD ^c, Adrien Bougle, MD, PhD ^d, Hélène Charbonneau, MD, PhD ^e, Martin Charvin, MD ^f, Bernard Cholley, MD, PhD ^g, Olivier Desebbe, MD ^h, Jean-Luc Fellahi, MD, PhD ⁱ, Denis Frasca, MD, PhD ^j, François Labaste, MD, PhD ^k, Diane Lena, MD ^l, Yazine Mahjoub, MD, PhD ^m, Paul-Michel Mertes, MD, PhD ⁿ, Serge Molliex, MD, PhD ^o, Pierre-Henri Moury, MD ^p, Mouhamed Djahoum Moussa, MD ^q, Jean-Ferreol Oilleau, MD ^r, Alexandre Ouattara, MD, PhD ^s, Sophie Provenchere, MD, PhD ^t, Bertand Rozec, MD, PhD ^u, Jean-Jacques Parienti, MD, PhD ^v, Marc-Olivier Fischer, MD, PhD ^w
the OPTIPAM investigators
^a Department of Anesthesiology and Critical Care Medicine, Caen University Hospital, Caen, France
^b Institute of Perfusion, Critical Care Medicine and Anesthesiology in Cardiac Surgery (IPRA), Hôpital Privé Jacques Cartier, Massy, France
^c Normandie Univ, UNIROUEN, INSERM U1096, CHU Rouen, Department of Anesthesiology and Critical Care, Rouen, France
^d Sorbonne Université, GRC 29, Assistance Publique – Hôpitaux de Paris, DMU DREAM, Département d'Anesthésie et Réanimation, Institut de Cardiologie, Hôpital La Pitié-Salpêtrière, Paris, France
^e Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, France
^f CHU Clermont-Ferrand, Médecine Péri-Opératoire (MC, FL, PJ, A-LC, EF); Université Clermont-Auvergne (EF), France
^g AP-HP, Hôpital Européen Georges Pompidou, Paris, France
^h Department of Anesthesiology and Intensive Care, Ramsay Sante Sauvegarde Clinic, Lyon, France.
ⁱ Service d'anesthésie-Réanimation, Hôpital Louis Pradel, Boulevard Pinel, Bron Cedex, France
^j Department of Anaesthesia and Intensive Care, University Hospital of Poitiers, France
^k Anesthesiology and Intensive Care Department, University Hospital of Toulouse, Toulouse, France
^l Institut Arnault Tzanck, Cardiologie Médico-chirurgicale, Saint Laurent du Var, France
^m Anesthesia and Critical Care Medicine Department, Amiens University Medical Center, Amiens, France
ⁿ Service d'Anesthésie-Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
^o Department of Anaesthesiology and Critical Care Medicine, Hôpital Nord, Saint Etienne, France
^p Pôle Anesthésie-Réanimation, CHU Grenoble Alpes, Grenoble, France
^q CHU Lille, Pôle d'Anesthésie-Réanimation, Lille, France
^r Department of Anaesthesia and Critical Care, Brest University Hospital, Brest, France
^s CHU Bordeaux, Department of Anaesthesia and Critical Care, Magellan Medical Surgical Centre, Bordeaux, France
^t Anesthesiology and surgical critical care department, DMU PARABOL, AP-HP, Bichat Hospital, Paris, France
^u Service d'Anesthésie-Réanimation, Hôpital Laënnec, Centre Hospitalier Universitaire, Nantes France
^v Department of Biostatistics and Clinical Research, Caen University Hospital, Caen, France
^w Clinique Saint Augustin, Institut Aquitain du Coeur, Bordeaux Cedex, France

^⁎Reprint requests: Richard Descamps, MD, Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire de Caen, Avenue de la Côte de Nacre, 14033 Caen, France.Department of Anesthesiology and Critical CareCentre Hospitalier Universitaire de CaenAvenue de la Côte de NacreCaen14033France

Riassunto

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 65 mm Hg or more during both the intraoperative and postoperative periods in 1,100 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 end points 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. Two interim analyses 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.

Clinical trial registration

NCT05403697

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Rationale

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Vol 261

P. 10-20 - luglio 2023 Ritorno al numero

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Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial - 22/05/23

Riassunto

Background

Study design

Conclusion

Clinical trial registration

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