Case stories & studies

Endotoxin Removal in Septic Shock with the Alteco^® LPS Adsorber was Safe But Showed No Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial - the Asset Study

The termination was made due to difficulties in recruiting subjects, despite modifying the inclusion criteria. The intended number of subjects was 32-44, but the included number of subjects according to protocol was only 8. Because of the low number of subjects recruited according to protocol, any observed differences between the Alteco LPS Adsorber and placebo device groups may be due to random variation. It is therefore not possible to draw any conclusions with respect to performance based on the data collected in this clinical investigation. Adverse event data, safety laboratory, vital sign and Richmond Agitation-Sedation Scale data provide no evidence of any risks associated with Alteco LPS Adsorber treatment.

Clinical effects of adsorption of lipopolysaccharide in the treatment of Gram-negative severe sepsis

A statistically significant improvement in hemodynamics, oxygenation, and reduced markers of endotoxemia in group therapy with Alteco LPS Adsorber compared with traditional therapy. These effects were attributed with the removal of endotoxin from the systemic circulation. Only in one case using hemofiltration for acute renal failure in the study group (in the reference group in all patients), 28-day mortality was 16.7% and 66.7% respectively. Negative effects were negligible.

A New Endotoxin Adsorber in Septic Shock: Observational Case Series

Two-hour hemoperfusion with Alteco LPS Adsorber was initiated in patients with septic shock and endotoxemia. Controls were matched for age, focus and severity of illness. Alteco LPS Adsorber treatment was associated with a decrease in noradrenaline dose, decrease in SOFA scores and LPS concentrations.

Clinical experience with lipopolysaccharide adsorber in cancer patients with severe sepsis and septic shock

After LPS adsorption with Alteco LPS Adsorber, the LPS level in patient serum was significantly reduced. Simultaneously, concentrations of some cytokines (IL-6, TNFβ, IL-8) were reliably decreased. But the Alteco LPS Adsorber probably does not eliminate soluble receptors like sCD14 and RIL-1 from blood. So the LPS adsorption may represent a significant improvement in the treatment of cancer patients with severe gram-negative sepsis and septic shock.

A lipopolysaccharide adsorber in adult cardiopulmonary bypass: a single center randomized controlled pilot trial

This study demonstrated the Alteco LPS Adsorber to be safe in a complex cardiac surgery setting.

Endotoxin Elimination in Patients with Septic Shock: An Observational Study

Endotoxin elimination was performed using hemoperfusion with the Alteco LPS Adsorber. Effective endotoxin elimination resulted in a significant improvement in hemodynamic parameters and of organ function. The application of the EA assay was useful for the bedside monitoring of endotoxemia in critically ill ICU patients.

Clinical experience with a novel endotoxin adsorption device in patients undergoing cardiac surgery

No adverse events were encountered when the Alteco LPS Adsorber was used in the circuit. Blood flow through the device was easily monitored and kept at the desired level. The Alteco LPS Adsorber can be used safely and is easy to handle in the bypass circuit. No complications related to the use of the device were noted.

Selective adsorption of endotoxin in the complex treatment of patients with severe sepsis

A session with Alteco LPS Adsorber caused a significant drop in the blood level of endotoxin and procalcitonin and it was accompanied by a trend toward better hemodynamics and lung gas exchange and alleviated organ dysfunction.