Volume 8, Issue 3, May 2020, Page: 89-100
Continuous 4 Percent Albumin Versus Intermittent 20 Percent Albumin in Adults with Septic Shock: A Prospective, Phase IV, Open-label Randomized Trial
Francis Schneider, Medical Intensive Care, Hautepierre Hospital I, University 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
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; ICUBE, Laboratory of Engineer Science, Computer Science and Imagery, Faculty of Physic and Engineering, University of Strasbourg, Illkirch, France
Marie-Hélène Metz-Boutigue, BioMaterials and BioEngineering, National Institute of Health and Medical Research, Faculty of Odontology, University of Strasbourg, Strasbourg, France
Received: Mar. 13, 2020;       Accepted: Mar. 30, 2020;       Published: Apr. 23, 2020
DOI: 10.11648/j.ajim.20200803.11      View  62      Downloads  48
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.
Keywords
Albumin, Care-related Infection, Outcome, Oxidative Stress, Septic Shock
To cite this article
Francis Schneider, Vincent Castelain, Guillaume Morel, Anne-Florence Dureau, Antoine Poidevin, Pierre-Olivier Ludes, Thibaut Fabacher, Bernard Senger, Nicolas Meyer, Marie-Hélène Metz-Boutigue, 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. Vol. 8, No. 3, 2020, pp. 89-100. doi: 10.11648/j.ajim.20200803.11
Copyright
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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