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

• Published in: Current controlled trials in cardiovascular medicine 2016-08, Vol.17 (1), p.384-384, Article 384
• Main Authors: Pettilä, Ville, Merz, Tobias, Wilkman, Erika, Perner, Anders, Karlsson, Sari, Lange, Theis, Hästbacka, Johanna, Hjortrup, Peter Buhl, Kuitunen, Anne, Jakob, Stephan M, Takala, Jukka
• Format: Article
• Language: English
• Subjects: Analysis; Arterial Pressure - drug effects; Biomarkers - blood; Blood pressure; Cardiotonic Agents - therapeutic use; Cardiovascular Agents - adverse effects; Cardiovascular Agents - therapeutic use; Care and treatment; Clinical Protocols; Clinical trials; Combined Modality Therapy; Data Interpretation, Statistical; Ethics; Europe; Feasibility Studies; Fluid Therapy - adverse effects; Fluid Therapy - mortality; Health aspects; Hemodynamic monitoring; Hemodynamics; Hemodynamics - drug effects; Humans; Hypertension; Intensive care; Intervention; Ischemia; Lactic Acid - blood; Medical prognosis; Microcirculation - drug effects; Models, Statistical; Mortality; Oxygen saturation; Patients; Perfusion (Physiology); Prospective Studies; Regional Blood Flow; Renal replacement therapy; Renal Replacement Therapy - adverse effects; Renal Replacement Therapy - mortality; Research Design; Respiration, Artificial - adverse effects; Respiration, Artificial - mortality; Sample Size; Sepsis; Septic shock; Shock, Septic - diagnosis; Shock, Septic - mortality; Shock, Septic - physiopathology; Shock, Septic - therapy; Skin; Study Protocol; Time Factors; Treatment Outcome; Vasoconstrictor Agents - therapeutic use; Vasoconstrictors; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-016-1515-x

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. 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