Randomisierte kontrollierte multizentrische Studie zur Albuminersatztherapie im septischen Schock (ARISS-Studie)
Zusammenfassung der Projektergebnisse
Albumin is a key regulator of fluid distribution within the extracellular space and has several properties beyond its oncotic activity. The randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS) investigated whether the replacement with albumin and the maintenance of its serum levels of at least 30 g/l for 28 days improves survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. Adult patients (≥18 yr) with septic shock were randomly assigned within a maximum of 24 hours after the onset of septic shock to treatment or control groups. The treatment group received a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels were maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The control group was treated according to the usual practice. The primary end point was 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, total amount of fluid administration and total fluid balance in the ICU, and lengths of ICU and hospital stay. The study started inclusion of patients from 21st Oct 2019 (first patient in). After repeated reassessment, the study was prematurely terminated on the 2nd of May 2022 due to sustained low inclusion rates. Of 440 patients with septic shock included in the study from 23 German centers; 222 were randomized in the albumin group and 218 in the control group. The median age of patients was 69 years (range 23 to 89) and 290 (66%) of patients were male. The demographic and baseline characteristics were similar between the study groups. The primary efficacy variable 90-day survival showed no significant difference between treatment groups. Until day 90, 119 (57%) of the albumin treated patients survived as well as 113 (54.1%) of patients of the control group. The 28-day (69 vs. 62%, p=0.114) and 60-day (61 vs. 55%, p=0.187) survival showed a tendency towards a benefit of albumin administration compared to standard treatment without albumin. Difference between treatment groups in 28-day survival was more prominent in patients with higher baseline lactate (≤ vs. > 8mmol/l), however, 90-day survival shows no difference between treatment groups according to the baseline lactate level. Likewise, difference between treatment groups in 28-day survival was more prominent in patients with very low (< 20 g/l) and high (≥ 25 g/l) baseline albumin. The difference for the subgroup with high albumin levels holds also for 90-day survival. There was no significant difference between patients of albumin group and control group in the number of days on ICU without vasopressors or mechanical ventilation. In the perprotocol analysis, 428 patients, 220 of the albumin group and 208 of the control group, were included. Results of per-protocol analysis were completely in line with the main analysis. Overall, the frequencies of adverse events, whether sepsis related or not, were similar between the albumin and the control group.
Projektbezogene Publikationen (Auswahl)
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Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial. Trials, 21(1).
Sakr, Yasser; Bauer, Michael; Nierhaus, Axel; Kluge, Stefan; Schumacher, Ulricke; Putensen, Christian; Fichtner, Falk; Petros, Sirak; Scheer, Christian; Jaschinski, Ulrich; Tanev, Ivan; Jacob, David; Weiler, Norbert; Schulze, P. Christian; Fiedler, Fritz; Kapfer, Barbara; Brunkhorst, Frank; Lautenschlaeger, Ingmar ... & Gattinoni, Luciano
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Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS). Anaesthesist 2021 Jun;70(6):528-530
Sakr Y & Gattinonni L.
