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. Issue 2 (August 2020)

• Record Type: Journal Article
• Authors: Lipcsey, Miklos; Tenhunen, Jyrki; Pischke, Soeren E.; Kuitunen, Anne; Flaatten, Hans; De Geer, Lina; Sjölin, Jan; Frithiof, Robert; Chew, Michelle S.; Bendel, Stepani; Kawati, Rafael; Larsson, Anders; Mollnes, Tom Eirik; Tønnessen, Tor Inge; Rubertsson, Sten
• Is Part Of: Shock. Volume 54:Issue 2(2020)
• Publication Date: 2020-08
• Subjects: Endotoxins -- gram-negative bacteria -- hemoperfusion -- septic shock -- Abbreviations -- AE -- Adverse effects -- ALT -- Alanine aminotransferase -- AST -- Aspartate aminotransferase -- CIP -- Clinical investigation plan -- CRO -- Clinical research organization -- CRRT -- Continuous renal replacement therapy -- CT -- Computed tomography -- eCRF -- Electronic case report form -- eGFRCyst -- Estimated glomerular filtration rate based on Plasma Cystatin C -- HIT II -- Heparin-induced thrombocytopenia II -- HPLC-MS -- High-performance liquid chromatography coupled with mass spectrometry -- ICU -- Intensive care unit -- IMD -- Interventional medical device -- LAL -- Limulus amebocyte lysate assay -- LOS -- Length-of-stay -- MAP -- Mean arterial pressure -- PaO2/FiO2 -- Arterial oxygen tension/Fraction of inspired oxygen -- RRT -- Renal replacement therapy -- SAE -- Serious adverse effects -- SAPS II -- Simplified acute physiology score -- SIRS -- Systemic inflammatory response syndrome -- SOFA -- Sequential organ failure assessment score; Shock -- Periodicals; Shock -- Periodicals; Choc (Pathologie) -- Périodiques; Shock; Periodicals; 616.0475
• DOI: 10.1097/SHK.0000000000001503
• Languages: English
• ISSNs: 1073-2322

Abstract

ABSTRACT: 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. Trial registration: Clinicaltrials.gov NCT02335723. Registered: November 28, 2014. Abstract : Supplemental Digital Content is available in the text