Projektdaten

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Randomisierte kontrollierte multizentrische Studie zur Albuminersatztherapie im septischen Schock (ARISS-Studie)

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Albumin is a key regulator of fluid distribution within the extracellular space and possess several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Prospective randomized trials on the possible impact of albumin replacement in patients with septic shock are lacking. The aim of the present study is to investigate whether the replacement with albumin and the maintenance of its serum levels above 30 g/L for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. In this prospective, multicenter, randomised trial, adult patients with septic shock will be randomly assigned within a maximum of 24 hours after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group will receive a 60 gm loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained above 30 gm/L in the ICU for a maximum of 28 days following randomization using 40-80 gm human albumin 20% infusion. The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary end point is 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412 patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated. The study is expected to influence the every-day clinical practice and will have a direct impact on the guidelines of treating patients with septic shock.