Making SENSE - Sustained Effort Network for treatment of XXXX as a multicenter prospective registry.

@entity1 @entity3175 @entity1245 @entity3174 @entity1363 @entity2934 @entity159
BACKGROUND: Evidence regarding the different treatment options of @entity159 ( @entity159 ) in adults is scarce. Large randomized trials cover only one treatment at early stage and suggest the superiority of @entity1245 over placebo, of intravenous @entity2934 over intravenous @entity3175 or over intravenous @entity3174 alone, and of intramuscular @entity1363 over intravenous @entity2934 . However, many @entity1 will not be treated successfully with the first treatment step. A large randomized trial covering the treatment of established status (ESETT) has just been funded recently by the NIH and will not start before 2015, with expected results in 2018; a trial on the treatment of refractory status with general anesthetics was terminated early due to insufficient recruitment. Therefore, a prospective multicenter observational registry was set up; this may help in clinical decision-making until results from randomized trials are available. METHODS/DESIGN: SENSE is a prospective, multicenter registry for @entity1 treated for @entity159 . The primary objective is to document @entity1 characteristics, treatment modalities and in-house outcome of consecutive adults admitted for @entity159 treatment in each of the participating centres and to identify predictors of outcome. Pre-treatment, treatment-related and outcome variables are documented systematically. To allow for meaningful multivariate analysis in the @entity1 subgroups with refractory @entity159 , a cohort size of 1000 @entity1 is targeted. DISCUSSION: The results of the study will provide information about risks and benefits of specific treatment steps in different @entity1 groups with @entity159 at different points of time. Thus, it will support clinical decision-making and, furthermore, it will be helpful in the planning of treatment trials. TRIAL REGISTRATION: DRKS00000725.
