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Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial

Received: 13 March 2020     Accepted: 30 March 2020     Published: 23 April 2020
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Abstract

Whether a specific way of infusing albumin affects outcome in patients with major oxidative stress remains uncertain. To determine whether outcome measurements (survival, organ failure and care-related infections) are different according to different regimens of albumin infusion, we conducted a phase IV, randomized, open-label trial to compare the effects of continuous infusion of 4 percent albumin versus intermittent 20 percent albumin on outcome measurements in three third level-hospital intensive care unit (ICU) patients with septic shock. We randomly assigned 125 consecutive patients with septic shock when serum albumin became <20g/L. Patients received either 4 percent albumin (12.5mL/kg) continuously or 20 percent albumin (100mL over 1h/8h) intermittently (controls) until serum albumin ranged between 25 and 30g/L and norepinephrine could be weaned. The primary outcome measure was death from any cause during the 28-day period after randomization. The other outcome parameters were ICU- and hospital length of stay, serum albumin concentrations, SOFA score and lactate over the 4 days following inclusion, care-related infections and tolerance of albumin over the 28-day period after randomization. Data were analyzed with Bayesian methods. Of the 125 patients who underwent randomization, 63 received 4 percent albumin and 62 received 20 percent albumin; groups had balanced baseline characteristics. There were 19 deaths in the experimental group, as compared with 20 in the control group (Pr=0.40). The proportion of patients with new multiple-organ failure (assessed by daily SOFA) was similar in the groups (RR=0.71 [0.29-1.41], Pr=0.14). There were no differences in the medians [IQR]) numbers of days spent in the ICU (12.0 [7.5; 22.0] versus 13 [8.0; 24.5] days, Pr=0.23), in days spent within hospital (29.0 [10.5; 44.0] versus 24 [14.0; 46.8] days, Pr=0.32). In contrast, there were fewer patients with care-related infection in the study group, (14.3% versus 45.2%, Pr<0.001). Limitations concern lack of double blinding related to different regimens of infusion: this may impact results. To conclude, the continuous supply of 4 percent albumin in septic shock patients with serum albumin <20g/L decreases care-related infection (by two third) but does not result in better survival.

Published in American Journal of Internal Medicine (Volume 8, Issue 3)
DOI 10.11648/j.ajim.20200803.11
Page(s) 89-100
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

Albumin, Care-related Infection, Outcome, Oxidative Stress, Septic Shock

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Cite This Article
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    Francis Schneider, Vincent Castelain, Guillaume Morel, Anne-Florence Dureau, Antoine Poidevin, et al. (2020). Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial. American Journal of Internal Medicine, 8(3), 89-100. https://doi.org/10.11648/j.ajim.20200803.11

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    ACS Style

    Francis Schneider; Vincent Castelain; Guillaume Morel; Anne-Florence Dureau; Antoine Poidevin, et al. Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial. Am. J. Intern. Med. 2020, 8(3), 89-100. doi: 10.11648/j.ajim.20200803.11

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    AMA Style

    Francis Schneider, Vincent Castelain, Guillaume Morel, Anne-Florence Dureau, Antoine Poidevin, et al. Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial. Am J Intern Med. 2020;8(3):89-100. doi: 10.11648/j.ajim.20200803.11

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  • @article{10.11648/j.ajim.20200803.11,
      author = {Francis Schneider and Vincent Castelain and Guillaume Morel and Anne-Florence Dureau and Antoine Poidevin and Pierre-Olivier Ludes and Thibaut Fabacher and Bernard Senger and Nicolas Meyer and Marie-Hélène Metz-Boutigue},
      title = {Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial},
      journal = {American Journal of Internal Medicine},
      volume = {8},
      number = {3},
      pages = {89-100},
      doi = {10.11648/j.ajim.20200803.11},
      url = {https://doi.org/10.11648/j.ajim.20200803.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajim.20200803.11},
      abstract = {Whether a specific way of infusing albumin affects outcome in patients with major oxidative stress remains uncertain. To determine whether outcome measurements (survival, organ failure and care-related infections) are different according to different regimens of albumin infusion, we conducted a phase IV, randomized, open-label trial to compare the effects of continuous infusion of 4 percent albumin versus intermittent 20 percent albumin on outcome measurements in three third level-hospital intensive care unit (ICU) patients with septic shock. We randomly assigned 125 consecutive patients with septic shock when serum albumin became versus 13 [8.0; 24.5] days, Pr=0.23), in days spent within hospital (29.0 [10.5; 44.0] versus 24 [14.0; 46.8] days, Pr=0.32). In contrast, there were fewer patients with care-related infection in the study group, (14.3% versus 45.2%, Pr<0.001). Limitations concern lack of double blinding related to different regimens of infusion: this may impact results. To conclude, the continuous supply of 4 percent albumin in septic shock patients with serum albumin <20g/L decreases care-related infection (by two third) but does not result in better survival.},
     year = {2020}
    }
    

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    T1  - Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial
    AU  - Francis Schneider
    AU  - Vincent Castelain
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    AU  - Anne-Florence Dureau
    AU  - Antoine Poidevin
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    AU  - Nicolas Meyer
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    T2  - American Journal of Internal Medicine
    JF  - American Journal of Internal Medicine
    JO  - American Journal of Internal Medicine
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    AB  - Whether a specific way of infusing albumin affects outcome in patients with major oxidative stress remains uncertain. To determine whether outcome measurements (survival, organ failure and care-related infections) are different according to different regimens of albumin infusion, we conducted a phase IV, randomized, open-label trial to compare the effects of continuous infusion of 4 percent albumin versus intermittent 20 percent albumin on outcome measurements in three third level-hospital intensive care unit (ICU) patients with septic shock. We randomly assigned 125 consecutive patients with septic shock when serum albumin became versus 13 [8.0; 24.5] days, Pr=0.23), in days spent within hospital (29.0 [10.5; 44.0] versus 24 [14.0; 46.8] days, Pr=0.32). In contrast, there were fewer patients with care-related infection in the study group, (14.3% versus 45.2%, Pr<0.001). Limitations concern lack of double blinding related to different regimens of infusion: this may impact results. To conclude, the continuous supply of 4 percent albumin in septic shock patients with serum albumin <20g/L decreases care-related infection (by two third) but does not result in better survival.
    VL  - 8
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    ER  - 

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Author Information
  • Medical Intensive Care, Hautepierre Hospital I, University Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • Medical Intensive Care, Hautepierre Hospital I, University Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • Medical Intensive Care, Hautepierre Hospital I, University Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • Medical Intensive Care, E. Muller Hospital, Hospital Group Mulhouse-Sud Alsace, Mulhouse, France

  • Medical Intensive Care, E. Muller Hospital, Hospital Group Mulhouse-Sud Alsace, Mulhouse, France

  • Surgical Critical Care Department, Hautepierre Hospital II, Universitary Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • Group of Methods in Clinical Research, Public Health Department, Universitary Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • BioMaterials and BioEngineering, National Institute of Health and Medical Research, Faculty of Odontology, University of Strasbourg, Strasbourg, France

  • Group of Methods in Clinical Research, Public Health Department, Universitary Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France

  • BioMaterials and BioEngineering, National Institute of Health and Medical Research, Faculty of Odontology, University of Strasbourg, Strasbourg, France

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