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
| Autor: | Soeren Erik Pischke, Michelle S Chew, Stepani Bendel, Anders Larsson, Miklos Lipcsey, Jan Sjölin, Sten Rubertsson, Tor Inge Tønnessen, Anne Kuitunen, Tom Eirik Mollnes, Jyrki Tenhunen, Lina De Geer, Rafael Kawati, Robert Frithiof, Hans Flaatten |
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| Rok vydání: | 2019 |
| Předmět: |
Lipopolysaccharides
Male 030204 cardiovascular system & hematology Critical Care and Intensive Care Medicine Placebo Extracorporeal law.invention Placebos Sepsis 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Intensive care Humans Medicine VDP::Medisinske Fag: 700 Adverse effect Aged business.industry Septic shock Genitourinary system 030208 emergency & critical care medicine Middle Aged medicine.disease Shock Septic VDP::Medical disciplines: 700 Endotoxins Intensive Care Units Anesthesia Emergency Medicine lipids (amino acids peptides and proteins) Female business |
| Zdroj: | Shock. 54:224-231 |
| ISSN: | 1540-0514 1073-2322 |
| Popis: | This is a non-final version of an article published in final form in Lipcsey, Tenhunen, Pischke, Kuitunen, Flaatten, De Geer, Sjölin, Frithiof, Chew, Bendel, Kawati, Larsson, Mollnes, Tønnessen, Rubertsson. 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. Shock. 2020;54(2):224-231. Purpose: Lipopolysaccharides (LPS) are presumed to contribute to the inflammatory response in sepsis. We investigated if extracorporeal Alteco LPS Adsorber for LPS removal in early gram-negative septic shock was feasible and safe. Also, effects on endotoxin level, inflammatory response, and organ function were assessed. Methods: A pilot, double-blinded, randomized, Phase IIa, feasibility clinical investigation was undertaken in six Scandinavian intensive care units aiming to allocate 32 septic shock patients with abdominal or urogenital focus on LPS Adsorber therapy or a Sham Adsorber, therapy without active LPS binding. The study treatment was initiated within 12 h of inclusion and given for 6 h daily on first 2 days. LPS was measured in all patients. Results: The investigation was terminated after 527 days with eight patients included in the LPS Adsorber group and seven in the Sham group. Twenty-one adverse effects, judged not to be related to the device, were reported in three patients in the LPS Adsorber group and two in the Sham group. Two patients in the Sham group and no patients in the LPS Adsorber group died within 28 days. Plasma LPS levels were low without groups differences during or after adsorber therapy. The changes in inflammatory markers and organ function were similar in the groups. Conclusions: In a small cohort of patients with presumed gram-negative septic shock, levels of circulating endotoxin were low and no adverse effects within 28 days after LPS adsorber-treatment were observed. No benefit compared with a sham device was seen when using a LPS adsorber in addition to standard care. |
| Databáze: | OpenAIRE |
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