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.

Pettilä, Ville Yrjö Olavi; Merz, Tobias Michael; Wilkman, Erika; Perner, Anders; Karlsson, Sari; Lange, Theis; Hästbacka, Johanna; Hjortrup, Peter Buhl; Kuitunen, Anne; Jakob, Stephan; Takala, Jukka (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, 17(384), p. 384. BioMed Central 10.1186/s13063-016-1515-x

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BACKGROUND 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 <2 mmol/L) and without any inotropic or vasopressor agent. Secondary outcomes include individual components of the primary outcome, days alive without renal replacement, days alive without mechanical ventilation in 30 days, and new acute kidney injury. The sample size enables detection of a 13.5-h difference in the primary outcome with a type 1 error of 5 % and power of 80 %, assuming 25 % mortality and a mean of 650 h (SD 30) among the 30-day survivors. After 150 included patients the statistician masked for allocation group will recalculate the sample size potentially increasing the sample up to 300. The Data Safety and Monitoring Board (DSMB) will review the safety data after 100 patients. 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. TRIAL REGISTRATION ClinicalTrials.gov: NCT02579525 . Registered on 19 October 2015.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Pettilä, Ville Yrjö Olavi; Merz, Tobias Michael; Jakob, Stephan and Takala, Jukka

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

09 Aug 2016 15:31

Last Modified:

14 Aug 2016 02:09

Publisher DOI:

10.1186/s13063-016-1515-x

PubMed ID:

27484695

Uncontrolled Keywords:

Critical illness; Lactate; Mortality; Septic shock; Tissue perfusion; Vasopressor

BORIS DOI:

10.7892/boris.85620

URI:

https://boris.unibe.ch/id/eprint/85620

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