Pagel Judith-Irina, Hulde Nikolai, Kammerer Tobias, Schwarz Michaela, Chappell Daniel, Burges Alexander, Hofmann-Kiefer Klaus, Rehm Markus
Department of Anaesthesiology, Hospital of the University of Munich LMU, Marchioninistr. 15, 81377, Munich, Germany.
Department of Anaesthesiology, Surgical Clinic of Munich-Bogenhausen, Munich, Germany.
Trials. 2017 Jul 10;18(1):313. doi: 10.1186/s13063-017-2051-z.
This study aims to investigate the effects of a modified, balanced crystalloid including phosphate in a perioperative setting in order to maintain a stable electrolyte and acid-base homeostasis in the patient.
METHODS/DESIGN: This is a single-centre, open-label, randomized controlled trial involving two parallel groups of female patients comparing a perioperative infusion regime with sodium glycerophosphate and Jonosteril® (treatment group) or Jonosteril® (comparator) alone. The primary endpoint is to maintain a stable concentration of weak acids [A] according to the Stewart approach of acid-base balance. Secondary endpoints are measurement of serum phosphate levels, other acid-base parameters such as the strong ion difference (SID), the onset and severity of postoperative nausea and vomiting (PONV), electrolyte levels and their excretion in the urine, monitoring of renal function and glycocalyx components, haemodynamics, amounts of catecholamines and other vasopressors used and the safety of the infusion regime.
Perioperative fluid replacement with the use of currently available crystalloid preparations still fail to maintain a stable acid-base balance and experts agree that common balanced solutions are still not ideal. This study aims to investigate the effectivity and safety of a new crystalloid solution by adding sodium glycerophosphate to a standardized crystalloid preparation in order to maintain a balanced perioperative acid-base homeostasis.
EudraCT number 201002422520 . Registered on 30 November 2010.
本研究旨在探讨一种改良的含磷酸盐平衡晶体液在围手术期的效果，以维持患者稳定的电解质和酸碱平衡。
方法/设计：这是一项单中心、开放标签、随机对照试验，涉及两组平行的女性患者，比较围手术期输注含甘油磷酸钠的方案与Jonosteril®（治疗组）或单独使用Jonosteril®（对照组）的情况。主要终点是根据酸碱平衡的斯图尔特方法维持弱酸[A]的稳定浓度。次要终点包括血清磷酸盐水平的测定、其他酸碱参数如强离子差（SID）、术后恶心呕吐（PONV）的发生率和严重程度、电解质水平及其尿排泄量、肾功能和糖萼成分的监测、血流动力学、儿茶酚胺及其他血管升压药的使用量以及输注方案的安全性。
使用目前可用的晶体液制剂进行围手术期液体补充仍无法维持稳定的酸碱平衡，专家们一致认为常用的平衡溶液仍不理想。本研究旨在通过在标准化晶体液制剂中添加甘油磷酸钠来研究一种新的晶体液溶液维持围手术期酸碱平衡的有效性和安全性。
EudraCT编号201002422520。于2010年11月30日注册。
