International Differences in the Treatment of Sepsis

Clinical review: Blood purification for sepsis

“…Indeed, although mortality was only a secondary endpoint, the study was prematurely stopped because it was judged to be unethical to deprive patients of hemoadsorption. The decision to halt the study seems extremely debatable because it was based upon a secondary analysis of an underpowered study and a different outcome in a single patient would have abolished the statistical difference in mortality [44]. Moreover, the fact that the study was controlled is also debatable since hemodynamic and respiratory parameters were only analyzed independently within each group, comparing 72 hour to baseline levels.…”

Clinical Trial Report—Polymyxin B Hemoperfusion: Effective, or Not?

“…Moreover, because the present study was stopped early, it lost statistical power for the outcomes under question, limiting the conclusions that can be drawn [3]. The decision to stop the trial early has been questioned, especially because the statistical difference in mortality would no longer have been present if just one patient had experienced a different outcome [4]. It is somewhat puzzling to read that the authors stopped the study early, but then call for a more complete study.…”

Extracorporeal Renal Replacement Therapies in the Treatment of Sepsis: Where Are We?

“…58 Also of note were significant regional differences in the management of sepsis given that blood purification techniques are common in some parts of the world and not others. 59 Furthermore, there was no standard reporting, with differing end points across trials, however, the investigators concluded that "there may be a role for this form of treatment in a disease that has, so far, eluded effective therapy." 59 Perhaps in answer to these questions we await the results of the first blinded and randomized, controlled, diagnostic-directed trial of a hemoperfusion device: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock.…”

“…59 Furthermore, there was no standard reporting, with differing end points across trials, however, the investigators concluded that "there may be a role for this form of treatment in a disease that has, so far, eluded effective therapy." 59 Perhaps in answer to these questions we await the results of the first blinded and randomized, controlled, diagnostic-directed trial of a hemoperfusion device: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock. 60 This study differs from previous work in that not only is it a multicenter, placebo-controlled (using a façade hemoperfusion setup), and randomized trial, but it also is a theragnostic trial.…”