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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.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Hedenstierna laboratory.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care.
Department of Immunology, University of Oslo, 0450 Oslo, Norway..
Department of Intensive Care, University of Tampere and Tampere University Hospital, Tampere, Finland..
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2019 (English)In: Shock, ISSN 1073-2322, E-ISSN 1540-0514Article in journal (Refereed) Epub ahead of print
Abstract [en]

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, effect 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 thirty-two septic shock patients with abdominal or urogenital focus to LPS Adsorber therapy or a Sham Adsorber, therapy without active LPS-binding. The study treatment was initiated within 12 hours of inclusion and given for six hours daily on first two 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 to a sham device was seen when using a LPS adsorber in addition to standard care.

TRIAL REGISTRATION: Clinicaltrials.gov NCT02335723. Registered: November 28, 2014.

Place, publisher, year, edition, pages
2019.
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Anesthesiology and Intensive Care
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URN: urn:nbn:se:uu:diva-400609DOI: 10.1097/SHK.0000000000001503PubMedID: 31880758OAI: oai:DiVA.org:uu-400609DiVA, id: diva2:1381856
Available from: 2019-12-28 Created: 2019-12-28 Last updated: 2019-12-28

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