Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomize
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Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial Yasser Sakr1* , Michael Bauer1, Axel Nierhaus2, Stefan Kluge2, Ulricke Schumacher3, Christian Putensen4, Falk Fichtner5, Sirak Petros6, Christian Scheer7, Ulrich Jaschinski8, Ivan Tanev9, David Jacob10, Norbert Weiler11, P. Christian Schulze12, Fritz Fiedler13, Barbara Kapfer14, Frank Brunkhorst3, Ingmar Lautenschlaeger11, Katja Wartenberg15, Stefan Utzolino16, Josef Briegel17, Onnen Moerer18, Petra Bischoff19, Alexander Zarbock20, Michael Quintel18,21, Luciano Gattinoni18 and on behalf of SepNet - Critical Care Trials Group
Abstract Background: Albumin is a key regulator of fluid distribution within the extracellular space and has several properties beyond its oncotic activity. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Methods/design: The randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS) investigates whether the replacement with albumin and the maintenance of its serum levels of at least 30 g/l for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. Adult patients (≥ 18 years) with septic shock are randomly assigned within a maximum of 24 h after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group receive a 60-g loading dose of human albumin 20% over 2–3 h. Serum albumin levels are 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 is treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary endpoint is 90 days mortality and secondary endpoints 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. In total, 1412 patients need to be analysed, 706 per group. For the sample size estimation, a 15% reduction in 90-day mortality is assumed, i.e. an absolute reduction of 7.5% points to 42.5% (relative risk 1.18). Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated. (Continued on next page)
* Correspondence: [email protected] 1 Department of Anesthesiology and Intensive Care Therapy, Jena University Hospital, Am Klinikum 1, 07743 Jena, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original au
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