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

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 >2mmol/l, and treated with norepinephrine for less than 12h 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 24h, 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 200mmHg for 5 min and then deflation to 0mmHg for another 5 min. RECO is performed at inclusion and repeated 12 and 24h 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.