Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial

Trials

Kada Klouche¹  Michel Ovize²  Martin Cour³  Laurent Argaud³  Radhia Bouzgarrou⁴  Fabrice Zeni⁵  Jean-Pierre Quenot⁶  Pascal Beuret⁷  Carole Schwebel⁸  Marielle Buisson⁹ 

[1] 0000 0000 9961 060X, grid.157868.5, Service de Réanimation Médicale, CHU de Montpellier, Montpellier, France;0000 0001 2172 4233, grid.25697.3f, Faculté de Médecine Lyon-Est, Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France;grid.413858.3, Centre d’investigation Clinique – INSERM 1407, Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France;0000 0001 2198 4166, grid.412180.e, Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Médecine Intensive-Réanimation, 5, place d’Arsonval, 69437, Lyon Cedex 03, France;0000 0001 2172 4233, grid.25697.3f, Faculté de Médecine Lyon-Est, Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France;0000 0004 0639 4151, grid.411163.0, Service de Réanimation Médicale, CHU Gabriel Montpied, Clermont-Ferrand, France;0000 0004 1765 1491, grid.412954.f, Service de Réanimation Médicale, CHU de Saint-Etienne, Saint-Etienne, France;Service de Réanimation Médicale, CHU François-Mitterrand, Dijon, France;Service de Réanimation polyvalente, CHR de Roanne, Roanne, France;grid.413746.3, Service de Réanimation Médicale, CHU Albert Michallon, Grenoble, France;grid.413858.3, Centre d’investigation Clinique – INSERM 1407, Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France;

关键词: Septic shock;    Intensive care;    Multiple organ failure;    Sequential Organ Failure Assessment (SOFA) score;    Remote ischemic conditioning;    Ischemia-reperfusion;    Reperfusion injury;   

DOI  :  10.1186/s13063-019-3406-4

来源: publisher

【 摘 要 】

BackgroundSeptic shock is a major public health problem that is associated with up to 50% mortality. Unfavorable outcomes are mainly attributed to multiple organ failure (MOF) resulting from an uncontrolled inflammatory response and ischemia-reperfusion processes. REmote ischemic COnditioning (RECO) is a promising intervention to prevent ischemia-reperfusion injury. We hypothesize that RECO would reduce the severity of septic shock-induced MOF.Methods/designRECO in septic shock patients (RECO-Sepsis study) is an ongoing, prospective, multicenter, randomized, open-label trial, testing whether RECO, as an adjuvant therapy to conventional treatment in septic shock, decreases the severity of MOF as assessed by the Sequential Organ Failure Assessment (SOFA) score. Adult patients admitted to an intensive care unit with documented or suspected infection, lactatemia > 2 mmol/l, and treated with norepinephrine for less than 12 h are potentially eligible for the study. Non-inclusion criteria are: having expressed the wish not to be resuscitated, contraindication for the use of a brachial cuff on both arms, intercurrent disease with an expected life expectancy of less than 24 h, cardiac arrest, and pregnant or breastfeeding women. After enrollment, patients are randomized (n = 180) 1:1 to receive RECO or no adjunctive intervention. RECO consists of four cycles of cuff inflation to 200 mmHg for 5 min and then deflation to 0 mmHg for another 5 min. RECO is performed at inclusion and repeated 12 and 24 h later. The primary endpoint is the mean daily SOFA score up to day 4 after inclusion. Secondary outcomes include the need for organ support, hospital length of stay, and 90-day mortality.DiscussionResults of this proof-of-concept trial should provide information on the efficacy of RECO in patients with septic shock.Trial registrationClinicalTrials.gov, ID: identifier: NCT03201575. Registered on 28 June 2017.

【 授权许可】

CC BY