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

Francis Schneider (1, 2, 3) , Vincent Castelain (2, 3) , Guillaume Morel (3, 2) , Anne-Florence Dureau (4) , Antoine Poidevin (4) , Pierre-Olivier Ludes (2, 3) , Thibaut Fabacher (5, 3) , Bernard Senger (1) , Nicolas Meyer (6, 3, 5) , Marie-Hélène Metz-Boutigue (1)

1 BB - Biomatériaux et Bioingénierie
2 Hôpital de Hautepierre [Strasbourg]
3 FMTS - Fédération de Médecine Translationnelle de Strasbourg
4 CH E.Muller Mulhouse - Centre Hospitalier Emile Muller [Mulhouse]
5 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
6 ICube - Laboratoire des sciences de l'ingénieur, de l'informatique et de l'imagerie

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.

Mots clés: Albumin; Care-related Infection; Outcome; Oxidative Stress; Septic Shock

Domaines: Médecine humaine et pathologie; Pharmacologie; Santé publique et épidémiologie

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. American Journal of Internal Medicine, 2020, 8 (3), pp.89-100. ⟨10.11648/j.ajim.20200803.11⟩. ⟨hal-03711976⟩