Alteco endotoxin hemoadsorption in Gram-negative septic shock patients

Abstract

Background and Aims:

Severe sepsis and septic shock are common causes of mortality and morbidity in an intensive care unit setting. Endotoxin, derived from the outer membranes of Gram-negative bacteria, is considered a major factor in the pathogenesis of sepsis. This study investigated the effect of Alteco endotoxin hemoadsorption device on Gram-negative septic shock patients.

Materials and Methods:

An open, controlled, prospective, randomized, single-center trial was conducted between February 2010 and June 2012. Patients with septic shock due to intra-abdominal sepsis were randomized to either conventional therapy ( n = 8) or conventional therapy plus two 2-hourly sessions of Alteco endotoxin hemoadsorption ( n = 7). Primary endpoint was the Sequential Organ Failure Assessment (SOFA) score changes from 0 to 72 h. Secondary end points included vasopressor requirement, PaO ₂/FiO ₂ ratio (PFR), length of stay (LOS), and 28-day mortality.

Results:

This study was terminated early as interim analysis showed a low probability of significant findings. No significant difference was noted between the two groups with respect to change in SOFA score, vasopressor score, PFR, LOS, and 28-day mortality. Side-effect was minimal.

Conclusions:

We could not identify any clinical benefit on the addition of Alteco endotoxin hemoadsorption to conventional therapy in patients who suffered from intra-abdominal sepsis with shock. The side effect profile of this novel device was acceptable.