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9 citations found

IMMUNOMODULATION BY VASOPRESSORS

Stolk, RF;Bruse, N;Jansen, A;Ponce, IR;

Product: LIST™ HPT™ from Escherichia coli O113

Product: LIST™ HPT™ from Escherichia coli O113

  • IN VIVO EXPERIMENTAL HUMAN ENDOTOXEMIA

    Human endotoxemia experiments were conducted at the research unit of the Intensive
    Care department of the Radboud university medical center according to our standard
    protocol (21). Subjects refrained from caffeine and alcohol in the 24 h before the
    experiment and from food and drinks 10 h before the experiment. One venous canulae
    was placed in the antecubital vein, for fluid infusion and endotoxin administration.
    Subjects were pre-hydrated in the hour before LPS administration (1.5 L 2.5%
    glucose/0.45% saline) followed by 150 mL/h for 6 h (until the end of the experiment).
    Blood pressure monitoring and blood withdrawals were performed using an arterial
    cannula placed in the radial artery. In addition, ECG was continuously monitored and
    vital signs were recorded every 5 seconds on a Phillips MP50 patient monitor using an
    in-house developed data capturing system. Body temperature was measured every 30
    mins with infrared tympanic measurements (FirstTemp Genius 2, Covidien Geldermalsen,
    the Netherlands). At T=0, 1 ng/kg bodyweight LPS (E. coli type O113, Lot no. 94332B1;
    List Biological Laboratories, Campbell, USA) was administered intravenously to elicit a
    transient systemic inflammatory response.

    Product #9433 – GMP LPS Lipopolysaccharide List™ Hpt™ From Escherichia Coli Type O113

Human in vivo neuroimaging to detect reprogramming of the cerebral immune response following repeated systemic inflammation

Peters van Ton, AM;Leijte, GP;Franssen, GM;Bruse, N;Booij, J;Doorduin, J;Rijpkema, M;Kox, M;Abdo, WF;Pickkers, P;

Product: LIST™ HPT™ from Escherichia coli O113

  • 2.3. Experimental human endotoxemia

    Subjects were admitted twice to the intensive care research unit of the Radboud university medical center in Nijmegen, The Netherlands, to receive both LPS challenges. All subjects underwent the same procedures on both hospitalization days which were 7 days apart. One day prior to both admissions, subjects needed to refrain from alcohol and caffeine, and no food or drinks were allowed from 10 hours before start of the challenge days. After admission, an intravenous cannula was inserted in the antebrachial vein to administrate fluids and LPS. A radial artery catheter was placed to withdraw blood and monitor blood pressure continuously. One hour before the challenge, 1.5 L prehydration fluid (2.5% Glucose/0.45% NaCl) was administered. Subsequently, a bolus of 2 ng/kg LPS (E. coli type O113, Lot no. 94332B1; List Biological Laboratories, Campbell, USA) was administered intravenously and similar hydration fluid was continued at an infusion rate of 150 mL/h for 8 hours. Heart rate was monitored using a 4-lead electrocardiogram (M50 Monitor, Philips, Eindhoven, The Netherlands) and intra-arterial blood pressure was measured with a pressure transducer (Edward Lifesciences, Irvine, USA). Every 30 minutes, we measured core temperature with a tympanic thermometer (FirstTemp Genius 2, Covidien, Dublin, Ireland) and LPS-induced symptoms (headache, nausea, cold shivers, muscle- and back pain) were scored using a numeric six-point scale (0 = no symptoms, 5 = worst symptoms experienced ever). The sum of these scores in addition of 3 points in case of vomiting, resulted in a total symptom score ranging from 0 to 28. Blood was withdrawn before prehydration (T = -60 minutes), just before LPS administration (T = 0 minutes), and respectively 60, 90, 120, 180, 240, 360 and 480 minutes after the LPS bolus. Plasma cytokine concentrations (tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-8, IL-10, macrophage inflammatory protein (MIP)-1α, MIP-1β, monocyte chemoattractant protein (MCP)-1 and IL-1RA (receptor antagonist)) were determined batchwise using a simultaneous luminex assay (Milliplex, Millipore, Billerica, USA).

    Product #9433 – GMP LPS Lipopolysaccharide List™ Hpt™ From Escherichia Coli Type O113

Low Plasma Gelsolin Concentrations in Chronic Granulomatous Disease

Audley, J;Gliniewicz, EF;Zarember, KA;Hong, HS;Wald, G;Kuhns, DB;Kang, E;Malech, HL;Suffredini, AF;Noveck, RJ;Dinubile, MJ;Levinson, SL;Stossel, TP;Gallin, JI;

Product: LIST™ HPT™ from Escherichia coli O113

Product: LIST™ HPT™ from Escherichia coli O113

Product: LIST™ HPT™ from Escherichia coli O113

  • Experimental Human Endotoxemia:

    Purified LPS (continuous infusion study: Escherichia coli O:113, Lot no. 94332B4, List Biological Laboratories, Campbell, USA; bolus administration study: US Standard Reference Endotoxin Escherichia coli O:113, Pharmaceutical Development Section of the National Institutes of Health, Bethesda, USA) was supplied as a lyophilized powder and dissolved in normal saline 0.9% as described previously [23,24]. For the continuous infusion study (c-LPS), a total of 4 ng/kg LPS was administered as a intravenous loading bolus of 1 ng/kg body weight at T = 0, followed by an intravenous infusion of 1 ng/kg/h for a period of 3 h [24]. For the bolus administration study (b-LPS), LPS was administered, as described previously, as an intravenous bolus injection at a dose of 2 ng/kg body weight in 1 min at T = 0 [23].

    All subjects received 1.5 L of 2.5% glucose/0.45% saline solution in the hour before initiation of LPS administration, followed by 150 mL/h during the first 6 h after LPS administration and 75 mL/h until the end of the experiment, according to our protocol [24].

    Product #9433 – GMP LPS Lipopolysaccharide List™ Hpt™ From Escherichia Coli Type O113

Comparison of different lots of endotoxin and evaluation of in vivo potency over time in the experimental human endotoxemia model

Kiers, D;Leijte, G;Gerretsen, J;Zwaag, J;Kox, M;Pickkers, P;

Product: LIST™ HPT™ from Escherichia coli O113

  • Endotoxin:

    All endotoxin lots were derived from an E. coli Type O113:H10:K-negative strain of bacteria. Endotoxin was stored at the investigational site in a dedicated fridge at 28C, and reconstituted prior to administration, both according to the manufacturers instructions. The temperature of the fridge was constantly monitored and logged using an automated system. Lot #1188844 was derived from bulk material produced by the National Institute of Allergy and Infectious Diseases and FDA in 1967 and vialled in 2006 under GMP conditions by the Pharmaceutical Development Section of the NIH (Bethesda, MD, USA). The lots #94332B1 and #94332B4 were both derived from the same new GMP-grade bulk material and vialled under GMP conditions by List Biological Laboratories, Inc (Campbell, California, USA). This GMP-grade endotoxin has previously shown to be safe for administration in humans.

    Product #9433 – GMP LPS Lipopolysaccharide List™ Hpt™ From Escherichia Coli Type O113

Experimental human endotoxemia as a model of systemic inflammation

van Lier, D;Geven, C;Leijte, GP;Pickkers, P;

Product: LIST™ HPT™ from Escherichia coli O113

Safety, tolerability and pharmacokinetics/-dynamics of the adrenomedullin antibody Adrecizumab in a first-in-human study and during experimental human endotoxemia in healthy subjects

Geven, C;van Lier, D;Blet, A;Peelen, R;Ten Elzen, B;Mebazaa, A;Kox, M;Pickkers, P;

Product: LIST™ HPT™ from Escherichia coli O113