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

Francis Schneider; Vincent Castelain; Guillaume Morel; Anne-Florence Dureau; Antoine Poidevin; Pierre-Olivier Ludes; Thibaut Fabacher; Bernard Senger; Nicolas Meyer; Marie-Hélène Metz-Boutigue

doi:doi:10.11648/j.ajim.20200803.11

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

Francis Schneider, Vincent Castelain, Guillaume Morel, Anne-Florence Dureau, Antoine Poidevin, Pierre-Olivier Ludes, Thibaut Fabacher, Bernard Senger, Nicolas Meyer, Marie-Hélène Metz-Boutigue

Published in American Journal of Internal Medicine (Volume 8, Issue 3)

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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APA Style

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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TY  - JOUR
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
AU  - Guillaume Morel
AU  - Anne-Florence Dureau
AU  - Antoine Poidevin
AU  - Pierre-Olivier Ludes
AU  - Thibaut Fabacher
AU  - Bernard Senger
AU  - Nicolas Meyer
AU  - Marie-Hélène Metz-Boutigue
Y1  - 2020/04/23
PY  - 2020
N1  - https://doi.org/10.11648/j.ajim.20200803.11
DO  - 10.11648/j.ajim.20200803.11
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 89
EP  - 100
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20200803.11
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
IS  - 3
ER  -

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Author Information

Francis Schneider

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

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

Medical Intensive Care, Hautepierre Hospital I, University Hospital of Strasbourg, Federation of Translational Medicine, Faculty of Medicine, University of Strasbourg, Strasbourg, France
Anne-Florence Dureau

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

Medical Intensive Care, E. Muller Hospital, Hospital Group Mulhouse-Sud Alsace, Mulhouse, France
Pierre-Olivier Ludes

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

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
Bernard Senger

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

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
Marie-Hélène Metz-Boutigue

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

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APA Style

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}
}

Copy | Download

TY  - JOUR
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
AU  - Guillaume Morel
AU  - Anne-Florence Dureau
AU  - Antoine Poidevin
AU  - Pierre-Olivier Ludes
AU  - Thibaut Fabacher
AU  - Bernard Senger
AU  - Nicolas Meyer
AU  - Marie-Hélène Metz-Boutigue
Y1  - 2020/04/23
PY  - 2020
N1  - https://doi.org/10.11648/j.ajim.20200803.11
DO  - 10.11648/j.ajim.20200803.11
T2  - American Journal of Internal Medicine
JF  - American Journal of Internal Medicine
JO  - American Journal of Internal Medicine
SP  - 89
EP  - 100
PB  - Science Publishing Group
SN  - 2330-4324
UR  - https://doi.org/10.11648/j.ajim.20200803.11
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
IS  - 3
ER  -

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