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 <i>versus</i> 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] <i>versus</i> 13 [8.0; 24.5] days, Pr=0.23), in days spent within hospital (29.0 [10.5; 44.0] <i>versus</i> 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% <i>versus</i> 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.
Highlights
Meta-analyses about resuscitation using albumin in critically ill patients at risk of complications have concluded that human albumin solutions were not robustly effective at reducing all-cause mortality [1,2,3]
We present the final analysis of a randomized trial which was stopped for futility on mortality and for an ethical issue linked to unexpected good impact of the experimental treatment on a secondary outcome
There were more chronic renal insufficiency patients in the 20 percent albumin group (Pr=0.02) (Table 1), and patients with solid cancer in remission >1 year were more represented in the 4 percent albumin group (Pr=0.99) (Table 1)
Summary
Meta-analyses about resuscitation using albumin in critically ill patients at risk of complications have concluded that human albumin solutions were not robustly effective at reducing all-cause mortality [1,2,3]. Attention has mainly been paid to fluid resuscitation of shock. These reports have left unsolved issues related to non-oncotic properties of therapeutic albumin [4], among which are timing of albumin administration, amounts of albumin to deliver, and the concentrations of the drug required to impact positively on outcome. Well-designed studies suggest that: 1) an early timing of albumin improves microvascular perfusion [5]; 2) 4 percent albumin be better for early fluid resuscitation [3] and 20 percent albumin for maintaining normal serum albumin concentrations [6] and at improving oxygenation in ARDS (acute respiratory distress syndrome) patients as well [7]. Whether any form of therapeutic albumin protects in vivo against infection is suggested in some studies [10, 11], but the benefit of albumin in septic conditions seems of borderline importance [2]
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