Type of study
EUPHAS 2 is a web-based patient registry for the collection of clinical data from patients with septic shock undergoing polymyxin B hemoperfusion therapy (PMX-HP, medical device Toraymyxin®, Toray Medical Ltd, Japan). The study is an observational cohort study divided into two phases, 1 and 2, a retrospective and prospective data collection, respectively.
Phase 1 was a retrospective data collection, which collected data from 357 patients in the period from January 2010 to December 2014 [1, 2]. Phase 2 is a prospective open-ended data collection started in January 2015.
EUPHAS 2 aims to strengthen the knowledge of the decision-making process leading to therapy prescription and to evaluate the effectiveness of the therapy. EUPHAS 2 also aims to identify subpopulations of patients who may benefit from this treatment more than others.
Study outcome measures
The collected data will include the following information: demographics, medical history, vital signs, diagnosis of septic shock, blood culture results, underlying diseases, infection source, treatment with other medical devices. Pre- and post-treatment variables include blood analysis, vital signs, vasoactive medication, diuresis, organ function scores, hemodynamic variables and results of blood gas analysis.
TORAY Medical Ltd. is the sponsor of the EUPHAS 2 project. TORAY will not claim any ownership of collected data. The same applies to members of the Scientific Steering Committee. Members of the SSC have access to the database in order to evaluate and analyze its content. Individual centers are the owners and managers of the data they enter: they can see, analyze or modify them any time needed until the final approval by the Scientific Secretary. The SSC has the full authority to decide which data should be published, where and when they should be published. The SSC also has the full authority to make decisions about content and authorship.
- Collaborative-Group, Polymyxin B hemoperfusion in clinical practice: the picture from an unbound collaborative registry. Blood Purif, 2014. 37 Suppl 1: p. 22-5. (Pubmed)
- Cutuli, S.L., et al., Polymyxin-B hemoperfusion in septic patients: analysis of a multicenter registry. Ann Intensive Care, 2016. 6(1): p. 77. (Pubmed)