Lv Cheng, Zhou Bin, Zhang Donghua, Lin Jiajia, Sun Lingling, Zhang Zhenzhen, Ding Yuan, Sun Rong, Zhang Jie, Zhou Chuyao, Zhang Li, Wang Xuan, Ke Lu, Li Weiqin, Li Baiqiang
Department of Critical Care Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Department of Anaesthesiology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
Front Surg. 2022 Oct 20;9:1019570. doi: 10.3389/fsurg.2022.1019570. eCollection 2022.
The ideal crystalloid fluid of choice for fluid therapy during liver transplantation is unknown. Conventional balanced crystalloids are buffered with organic anions, which requires liver metabolism to prevent matabolic acidosis and protect renal function. Therefore they can not function properly during liver transplantation. On the contrary, the bicarbonated Ringer's solution (BRS) can maintain acid-base status regardless of liver function. In this study, we aimed to test the hypothesis that, in patients undergoing orthotopic liver transplantation, compared with acetated Ringer's solutions (ARS), perioperative fluid therapy with BRS could better maintain the acid-base status.
This is a prospective, single-centre, randomised controlled trial. 72 eligible patients will be randomised to receive either BRS or ARS perioperatively. The primary endpoint is the difference in standard base excess (SBE) before and after operation. Secondary endpoints include the incidence of acute kidney injury (AKI) within 48 h post operation and free and alive days to day 14 for intensive care admission, invasive ventilation, vasopressors, and renal replacement therapy (RRT).
Metabolic acidosis is common perioperatively, potentially leading to decreased renal blood flow and reduced glomerular filtration rate. The use of balanced solutions can prevent hyperchloremic metabolic acidosis, thereby avoiding AKI in some patients. However, during liver transplantation, when well-functioning liver metabolism is lacking, the organic anions in conventional balanced solutions may remain strong anions and thus fail to maintain the acid-base status, but no solid clinical evidence exists now. This study will, for the first time, provide evidence on the relative effects of BRS vs. ARS on acid-base status and renal injury in patients undergoing liver transplantation.
The trial has been registered at the Chinese Clinical Trials Registry (ChiCTR2100046889) on 29 May 2021.
肝移植期间液体治疗的理想晶体液尚不清楚。传统的平衡晶体液用有机阴离子缓冲，这需要肝脏代谢以预防代谢性酸中毒并保护肾功能。因此，它们在肝移植期间不能正常发挥作用。相反，碳酸氢林格液（BRS）无论肝功能如何都能维持酸碱平衡。在本研究中，我们旨在验证以下假设：在接受原位肝移植的患者中，与醋酸林格液（ARS）相比，围手术期使用BRS进行液体治疗能更好地维持酸碱平衡。
这是一项前瞻性、单中心、随机对照试验。72例符合条件的患者将被随机分为围手术期接受BRS或ARS治疗。主要终点是手术前后标准碱剩余（SBE）的差异。次要终点包括术后48小时内急性肾损伤（AKI）的发生率，以及重症监护入院、有创通气、血管升压药和肾脏替代治疗（RRT）至第14天的存活天数。
围手术期代谢性酸中毒很常见，可能导致肾血流量减少和肾小球滤过率降低。使用平衡液可预防高氯性代谢性酸中毒，从而避免部分患者发生AKI。然而，在肝移植期间，由于缺乏正常的肝脏代谢功能，传统平衡液中的有机阴离子可能仍为强阴离子，因此无法维持酸碱平衡，但目前尚无确凿的临床证据。本研究将首次提供证据，证明BRS与ARS对肝移植患者酸碱平衡状态和肾损伤的相对影响。
该试验于2021年5月29日在中国临床试验注册中心（ChiCTR2100046889）注册。
