Martin Cour1,2, Kada Klouche3, Bertrand Souweine4, Jean-Pierre Quenot5, Carole Schwebel6, Sophie Perinel7, Camille Amaz8, Marielle Buisson8, Michel Ovize9,8, Nathan Mewton9,8, Laurent Argaud10,9. 1. Médecine Intensive-Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Médecine Intensive-Réanimation, 5, Place d'Arsonval, 69437, Lyon Cedex 03, France. martin.cour@chu-lyon.fr. 2. Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France. martin.cour@chu-lyon.fr. 3. Service de Médecine Intensive-Réanimation, CHU de Montpellier, Montpellier, France. 4. Service de Médecine Intensive-Réanimation, CHU Gabriel Montpied, Clermont-Ferrand, France. 5. Service de Médecine Intensive-Réanimation, CHU François-Mitterrand, Dijon, France. 6. Service de Médecine Intensive-Réanimation, CHU Albert Michallon, Grenoble, France. 7. Service de Médecine Intensive-Réanimation, CHU de Saint-Etienne, Saint-Etienne, France. 8. Centre d'Investigations Cliniques (CIC), Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France. 9. Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France. 10. Médecine Intensive-Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Médecine Intensive-Réanimation, 5, Place d'Arsonval, 69437, Lyon Cedex 03, France.
Abstract
PURPOSE: To determine whether remote ischemic conditioning (RECO), compared to standard care, limits the severity and the consequences of multiple organ failure in patients with septic shock. METHODS: The RECO-Sepsis trial, a prospective, multicenter, randomized, open-label, parallel group trial with blinded assessment of the outcome, was conducted at six intensive care units in France in adult patients with septic shock. Within 12 h after the onset of septic shock, patients were randomized (1:1 ratio) to receive either RECO applied by inflating/deflating (200/0 mmHg for 5/5 min) 4 times a cuff around an arm or a sham procedure every 12 h for 24 h. The primary endpoint was the severity of multiple organ failure assessed by the mean daily Sequential Organ Failure Assessment (SOFA) score from inclusion to the fourth day after inclusion (day 4). Patients were followed for 90 days. RESULTS: Among 180 randomized patients, 178 completed the trial (RECO group: 87; control group: 91) and were included in the intention-to-treat analysis (108 men [60.7%], median age 68 [59-75] years). There was no significant difference in the mean daily SOFA score between the intervention group and the control group (7.2 points [5.2-10.7] versus 7.6 points [4.9-10.7], respectively; p = 0.919). Cumulative mortality within 90 days was 27.6% in the RECO group and 39.6% control group (Log-rank test, p = 0.10; adjusted hazard ratio 0.59, 95% CI, 0.35 to 0.99; p = 0.049). CONCLUSIONS: In patients with septic shock, RECO failed to reduce the severity of organ failures assessed by mean daily SOFA score from inclusion to day 4. Adequately powered trials are needed to assess potential delayed benefits of RECO.
PURPOSE: To determine whether remote ischemic conditioning (RECO), compared to standard care, limits the severity and the consequences of multiple organ failure in patients with septic shock. METHODS: The RECO-Sepsis trial, a prospective, multicenter, randomized, open-label, parallel group trial with blinded assessment of the outcome, was conducted at six intensive care units in France in adult patients with septic shock. Within 12 h after the onset of septic shock, patients were randomized (1:1 ratio) to receive either RECO applied by inflating/deflating (200/0 mmHg for 5/5 min) 4 times a cuff around an arm or a sham procedure every 12 h for 24 h. The primary endpoint was the severity of multiple organ failure assessed by the mean daily Sequential Organ Failure Assessment (SOFA) score from inclusion to the fourth day after inclusion (day 4). Patients were followed for 90 days. RESULTS: Among 180 randomized patients, 178 completed the trial (RECO group: 87; control group: 91) and were included in the intention-to-treat analysis (108 men [60.7%], median age 68 [59-75] years). There was no significant difference in the mean daily SOFA score between the intervention group and the control group (7.2 points [5.2-10.7] versus 7.6 points [4.9-10.7], respectively; p = 0.919). Cumulative mortality within 90 days was 27.6% in the RECO group and 39.6% control group (Log-rank test, p = 0.10; adjusted hazard ratio 0.59, 95% CI, 0.35 to 0.99; p = 0.049). CONCLUSIONS: In patients with septic shock, RECO failed to reduce the severity of organ failures assessed by mean daily SOFA score from inclusion to day 4. Adequately powered trials are needed to assess potential delayed benefits of RECO.
Authors: Manu Shankar-Hari; Gary S Phillips; Mitchell L Levy; Christopher W Seymour; Vincent X Liu; Clifford S Deutschman; Derek C Angus; Gordon D Rubenfeld; Mervyn Singer Journal: JAMA Date: 2016-02-23 Impact factor: 56.272
Authors: Daniel De Backer; Maurizio Cecconi; Jeffrey Lipman; Flavia Machado; Sheila Nainan Myatra; Marlies Ostermann; Anders Perner; Jean-Louis Teboul; Jean-Louis Vincent; Keith R Walley Journal: Intensive Care Med Date: 2019-02-11 Impact factor: 17.440