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

Autor: Descamps R; Department of Anesthesiology and Critical Care Medicine, Caen University Hospital, Caen, France. Electronic address: descamps-r@chu-caen.fr., Amour J; Institute of Perfusion, Critical Care Medicine and Anesthesiology in Cardiac Surgery (IPRA), Hôpital Privé Jacques Cartier, Massy, France., Besnier E; Normandie Univ, UNIROUEN, INSERM U1096, CHU Rouen, Department of Anesthesiology and Critical Care, Rouen, France., Bougle A; 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., Charbonneau H; Department of Anesthesiology and Intensive Care Unit, Clinique Pasteur, France., Charvin M; CHU Clermont-Ferrand, Médecine Péri-Opératoire (MC, FL, PJ, A-LC, EF); Université Clermont-Auvergne (EF), France., Cholley B; AP-HP, Hôpital Européen Georges Pompidou, Paris, France., Desebbe O; Department of Anesthesiology and Intensive Care, Ramsay Sante Sauvegarde Clinic, Lyon, France., Fellahi JL; Service d'anesthésie-Réanimation, Hôpital Louis Pradel, Boulevard Pinel, Bron Cedex, France., Frasca D; Department of Anaesthesia and Intensive Care, University Hospital of Poitiers, France., Labaste F; Anesthesiology and Intensive Care Department, University Hospital of Toulouse, Toulouse, France., Lena D; Institut Arnault Tzanck, Cardiologie Médico-chirurgicale, Saint Laurent du Var, France., Mahjoub Y; Anesthesia and Critical Care Medicine Department, Amiens University Medical Center, Amiens, France., Mertes PM; Service d'Anesthésie-Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France., Molliex S; Department of Anaesthesiology and Critical Care Medicine, Hôpital Nord, Saint Etienne, France., Moury PH; Pôle Anesthésie-Réanimation, CHU Grenoble Alpes, Grenoble, France., Moussa MD; CHU Lille, Pôle d'Anesthésie-Réanimation, Lille, France., Oilleau JF; Department of Anaesthesia and Critical Care, Brest University Hospital, Brest, France., Ouattara A; CHU Bordeaux, Department of Anaesthesia and Critical Care, Magellan Medical Surgical Centre, Bordeaux, France., Provenchere S; Anesthesiology and surgical critical care department, DMU PARABOL, AP-HP, Bichat Hospital, Paris, France., Rozec B; Service d'Anesthésie-Réanimation, Hôpital Laënnec, Centre Hospitalier Universitaire, Nantes France., Parienti JJ; Department of Biostatistics and Clinical Research, Caen University Hospital, Caen, France., Fischer MO; Clinique Saint Augustin, Institut Aquitain du Coeur, Bordeaux Cedex, France.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2023 Jul; Vol. 261, pp. 10-20. Date of Electronic Publication: 2023 Mar 18.
DOI: 10.1016/j.ahj.2023.03.005
Abstrakt: 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.
Competing Interests: Conflict of interest None reported.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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