Pettila, VilleMerz, TobiasWilkman, ErikaKarlsson, SariPerner, AndersLange, TheisHästbacka, JohannaHjortrup, Peter BuhlKuitunen, AnneJakob, Stephan M.Takala, Jukka2016-10-032016-10-032016-08-02Pettila, V, Merz, T, Wilkman, E, Karlsson, S, Perner, A, Lange, T, Hästbacka, J, Hjortrup, P B, Kuitunen, A, Jakob, S M & Takala, J 2016, 'Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S) : study protocol and statistical analysis plan for a randomized controlled trial', Trials, vol. 17, 384. https://doi.org/10.1186/s13063-016-1515-xORCID: /0000-0002-3613-7231/work/39642706http://hdl.handle.net/10138/167373Background: Septic shock has a 90-day mortality risk of up to 50 %. The hemodynamic targets, including mean arterial pressure (MAP) are not based on robust clinical data. Both severe hypotension and high doses of vasopressors may be harmful. Hence, re-evaluation of hemodynamic targets in septic shock is relevant. Methods/design: The targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S) trial is a prospective, two-parallel-group, randomized, open-label, multicenter trial with assessor-blinded outcome evaluation. We will randomize at least 200 patients with septic shock in four European intensive care units (ICUs) to test whether a tissue perfusion-guided treatment strategy based on capillary refill time, peripheral temperature, arterial lactate concentrations, and accepting lower MAP levels, leads to a faster resolution of shock than macrocirculation target-guided standard care. The primary outcome measure is days alive in 30 days with normal arterial blood lactate (first value of Discussion: The TARTARE-2S trial will provide important clinical data on treatment targets in septic shock, evaluating the impact of clinical tissue perfusion-guided hemodynamic treatment on a surrogate outcome combining resolution of shock (hyperlactatemia and vasopressors/inotropes), and 30-day mortality.13engcc_byinfo:eu-repo/semantics/openAccessSeptic shockCritical illnessTissue perfusionLactateVasopressorMortalityCRITICALLY-ILL PATIENTSACUTE KIDNEY INJURYGOAL-DIRECTED RESUSCITATIONRENAL REPLACEMENT THERAPYARTERIAL-BLOOD PRESSURESEVERE SEPSISACCELERATED INITIATIONLACTATE CLEARANCEMORTALITYMULTICENTERSurgery, anesthesiology, intensive care, radiologyTargeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S) : study protocol and statistical analysis plan for a randomized controlled trialArticleopenAccess4e0afd2b-86ee-4474-b1e9-60ddfc089d6c84988419483000381077200006