Case stories and scientific reports
Endotoxin removal in septic E. Coli bacteremia during continuous veno-venous hemodiafiltration therapy
Endotoxin removal therapy stabilizes critical patient with ARDS, multiple infections and septic shock
Studies and references
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.
A case of a 64-year-old man with severe gram-negative sepsis was presented. To reduce the amplitude of the general effects of endotoxin the Alteco LPS Adsorber was used.
The efficacy markers were the overall hemodynamic profile, translated into decreased vasopressor requirements, the normalization of the cardiac index, and the systemic vascular resistance index combined with the lactate level and the reduction in procalcitonin levels. A decrease in the sequential organ failure assessment (SOFA) score at twenty-four hours was demonstrated.
The clinical course following treatment was favorable for the days immediately following the treatment. This was attributed to the removal of endotoxin from the systemic circulation.
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.
Thirteen patients with gram-negative sepsis underwent the procedure of selective lipopolysaccharide adsorption using Alteco LPS Adsorber (group I) or Toraymyxin columns (group II). This therapy positively influenced the course of sepsis. After the second procedure, levels of serum endotoxin and procalcitonin markedly decreased in both groups. We also discovered a positive effect on leukocytosis levels and a trend towards normalization of body temperature, improvement of hemodynamic indices and increase of the lung's oxygenating function. Blood cultures taken several days after the procedure were negative.
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.
After LPS adsorption with Alteco LPS Adsorber, the level of LPS in the patient's bloodstream was almost eliminated: from 1.44 EU/ml before treatment to 0.03 EU/ml post treatment. The procalcitonin level and inflammatory cytokines were concurrently reduced. Also, an obvious improvement in the status of the patient's hemodynamics was seen. Forty-five days after treatment the patient is still alive. LPS adsorption may represent a significant improvement in the treatment of gram-negative sepsis and further studies are planned.
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.
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.
Hemoperfusion with Alteco LPS Adsorber was performed to eliminate endotoxin from the bloodstream. Rapid pathogen identification, adequate antimicrobial therapy and endotoxin elimination from the bloodstream improved the hemodynamic and respiratory parameters of the patient. The application of routine plus non-standard methods of treatment of septic shock prevented the progression of the biological cascade in sepsis and improved the patient's clinical condition.
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.
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.