A Randomized Controlled Multicenter Trial on Albumin Replacement In Septic Shock (ARISS)

感染性休克白蛋白替代的随机对照多中心试验 (ARISS)

• 批准号: 328809707
• 负责人: Professor Dr. Michael Bauer, since 9/2022
• 金额: --
• 依托单位: Klinik für Anästhesiologie und Intensivmedizin
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2018
• 资助国家: 德国
• 起止时间: 2017-12-31 至 2022-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/328809707?language=en
• 关键词: Randomized; Controlled; Multicenter; Trial; Albumin

Albumin is a key regulator of fluid distribution within the extracellular space and posses 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 these patients with septic shock are lacking. The aim of the proposed 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 (~18 yr) 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 tobe 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 an the guidelines of treating patients with septic shock.

白蛋白是细胞外空间内液体分布的关键调节剂，并且除了其抗炎活性之外还具有几种性质，包括几种内源性分子的结合和转运、抗炎和抗氧化作用、一氧化氮调节和缓冲功能。越来越多的证据表明，补充白蛋白可能提供生存优势，只有当损伤是严重的感染性休克患者。缺乏关于白蛋白替代治疗对这些感染性休克患者可能影响的前瞻性随机试验。拟定研究的目的是研究与无白蛋白的复苏和容量维持相比，白蛋白替代并维持其血清水平高于30 g/L持续28天是否可改善脓毒性休克患者的生存率。在这项前瞻性、多中心、随机试验中，感染性休克成人患者（约18岁）将在获得知情同意后感染性休克发作后最多24小时内随机分配至治疗组或对照组。分配至治疗组的患者将在2-3小时内接受60 gm负荷剂量的人血白蛋白20%。在随机化后，使用40-80 gm人血白蛋白20%输注，ICU中的血清白蛋白水平将维持在30 gm/L以上，最长持续28天。对照组将按照常规做法进行治疗，晶体液作为败血性休克复苏和维持阶段的首选。主要终点是90天死亡率，次要终点包括28天、60天、ICU和住院死亡率、器官功能障碍/衰竭、ICU和住院时间。总共需要分析1412例患者，每组706例。假设脱落率为15%，共需要分配1662例患者。该研究预计将影响日常的临床实践，并将对脓毒性休克患者的治疗指南产生直接影响。