Kammerer Tobias, Klug Florian, Schwarz Michaela, Hilferink Sebastian, Zwissler Bernhard, von Dossow Vera, Karl Alexander, Müller Hans-Helge, Rehm Markus
Department of Anesthesiology, Hospital of the University of Munich, LMU Munich, Marchioninistrasse 15, 81377, Munich, Germany.
Department of Anesthesiology, Surgical Clinic Munich-Bogenhausen, Denninger Strasse 44, 81679, Munich, Germany.
Trials. 2015 Aug 28;16:384. doi: 10.1186/s13063-015-0866-z.
The use of artificial colloids is currently controversial, especially in Central Europe Several studies demonstrated a worse outcome in intensive care unit patients with the use of hydroxyethyl starch. This recently even led to a drug warning about use of hydroxyethyl starch products in patients admitted to the intensive care unit. The data on hydroxyethyl starch in non-critically ill patients are insufficient to support perioperative use.
METHODS/DESIGN: We are conducting a single-center, open-label, randomized, comparative trial with two parallel patient groups to compare human albumin 5% (test drug) with hydroxyethyl starch 6% 130/0.4 (comparator). The primary endpoint is cystatin C ratio, calculated as the ratio of the cystatin value at day 90 after surgery relative to the preoperative value. Secondary objectives are inter alia the evaluation of the influence of human albumin and hydroxyethyl starch on further laboratory chemical and clinical parameters, glycocalyx shedding, intensive care unit and hospital stay and acute kidney injury as defined by RIFLE criteria (risk of renal dysfunction, injury to the kidney, failure of kidney function, loss of kidney function, and end-stage kidney disease) criteria.
There is a general lack of evidence on the relative safety and effects of hydroxyethyl starch compared with human albumin for volume replacement in a perioperative setting. Previously conducted studies of surgical patients in which researchers have compared different hydroxyethyl starch products included too few patients to properly evaluate clinical important outcomes such as renal function. In the present study in a high-risk patient population undergoing a major surgical intervention, we will determine if perioperative fluid replacement with human albumin 5% will have a long-term advantage over a third-generation hydroxyethyl starch 130/0.4 on the progression of renal dysfunction until 90 days after surgery.
EudraCT number 2010-018343-34. Registered on 11 January 2010.
人工胶体的使用目前存在争议，尤其是在中欧地区。多项研究表明，在重症监护病房患者中使用羟乙基淀粉会导致更差的预后。最近这甚至导致了关于在重症监护病房住院患者中使用羟乙基淀粉产品的药物警示。关于羟乙基淀粉在非重症患者中的数据不足以支持其围手术期使用。
方法/设计：我们正在进行一项单中心、开放标签、随机、对照试验，将患者分为两个平行组，比较5%人血白蛋白（试验药物）和6% 130/0.4羟乙基淀粉（对照药物）。主要终点是胱抑素C比值，计算方法为术后90天的胱抑素值与术前值之比。次要目标包括评估人血白蛋白和羟乙基淀粉对其他实验室化学和临床参数、糖萼脱落、重症监护病房和医院住院时间以及根据RIFLE标准（肾功能障碍风险、肾损伤、肾功能衰竭、肾功能丧失和终末期肾病）定义的急性肾损伤的影响。
在围手术期进行容量替代时，与白蛋白相比，羟乙基淀粉的相对安全性和效果普遍缺乏证据。此前针对手术患者比较不同羟乙基淀粉产品的研究纳入患者过少，无法正确评估诸如肾功能等临床重要结局。在本研究中，针对接受重大手术干预的高危患者群体，我们将确定围手术期使用5%人血白蛋白进行液体替代是否在术后90天内肾功能障碍进展方面优于第三代羟乙基淀粉130/0.4。
欧盟临床试验注册号2010 - 018343 - 34。于2010年1月11日注册。
