The Impact of Normal Saline or Balanced Crystalloid on Plasma Chloride Concentration and Acute Kidney Injury in Patients With Predicted Severe Acute Pancreatitis: Protocol of a Phase II, Multicenter, Stepped-Wedge, Cluster-Randomized, Controlled Trial.
The Impact of Normal Saline or Balanced Crystalloid on Plasma Chloride Concentration and Acute Kidney Injury in Patients With Predicted Severe Acute Pancreatitis: Protocol of a Phase II, Multicenter, Stepped-Wedge, Cluster-Randomized, Controlled Trial.
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生理盐水或平衡晶体对预测的重症急性胰腺炎患者血浆氯化物浓度和急性肾损伤的影响：II 期、多中心、阶梯楔形、整群随机、对照试验方案
DOI：
10.3389/fmed.2021.731955
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发表时间：
2021
影响因子：
3.9
通讯作者：
Li W
中科院分区：
文献类型：
--
作者：
Ye B;Huang M;Chen T;Doig G;Wu B;Chen M;Tu S;Chen X;Yang M;Zhang G;Li Q;Pan X;Zhao L;Xia H;Chen Y;Ke L;Tong Z;Bellomo R;Windsor J;Li W
引言/目的：生理盐水的超生理氯化物浓度可能导致急性肾损伤（阿基）。平衡晶体可降低危重患者的氯化物浓度和阿基。我们的目的是检验这一假设，即在预测的重症急性胰腺炎（pSAP）患者中，与生理盐水相比，平衡晶体液体治疗将降低血浆氯浓度。方法/设计：这是一项多中心、阶梯楔形、随机分组、对照试验。将招募研究期间在中国11家参与研究中心就诊的所有合格患者。所有研究中心将在第一个月使用生理盐水，并在预定和随机分配的时间点依次更换为平衡晶体。主要终点是入组第3天的血浆氯化物浓度。次要终点将包括出院时或第30天（MAKE 30）的主要肾脏不良事件以及重症监护入院、有创通气、血管加压药和肾脏替代治疗的自由和存活天数至第30天。其他终点包括入组前7天的每日血清氯化物和序贯器官衰竭评估（SOFA）评分。讨论内容：本研究将提供数据，以确定生理盐水与平衡晶体液对pSAP患者血浆氯化物浓度和临床结局的影响。它还将提供必要的数据，为未来与液体治疗相关的大规模随机试验提供动力。伦理与传播：本研究获得了南京大学金陵医院伦理委员会（2020 NZKY-015-01）和所有参与中心的批准。这项试验的结果将在同行评审的期刊和科学会议上传播。试验注册：该试验已在中国临床试验注册中心注册（ChiCTR 2100044432）。
Introduction/aim: The supraphysiologic chloride concentration of normal saline may contribute to acute kidney injury (AKI). Balanced crystalloids can decrease chloride concentration and AKI in critically ill patients. We aim to test the hypothesis that, in patients with predicted severe acute pancreatitis (pSAP), compared with saline, fluid therapy with balanced crystalloids will decrease plasma chloride concentration. Methods/Design: This is a multicenter, stepped-wedge, cluster-randomized, controlled trial. All eligible patients presenting to the 11 participating sites across China during the study period will be recruited. All sites will use saline for the first month and sequentially change to balanced crystalloids at the pre-determined and randomly allocated time point. The primary endpoint is the plasma chloride concentration on day 3 of enrollment. Secondary endpoints will include major adverse kidney events on hospital discharge or day 30 (MAKE 30) and free and alive days to day 30 for intensive care admission, invasive ventilation, vasopressors, and renal replacement therapy. Additional endpoints include daily serum chloride and sequential organ failure assessment (SOFA) score over the first seven days of enrollment. Discussion: This study will provide data to define the impact of normal saline vs. balanced crystalloids on plasma chloride concentration and clinical outcomes in pSAP patients. It will also provide the necessary data to power future large-scale randomized trials relating to fluid therapy. Ethics and Dissemination: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (2020NZKY-015-01) and all the participating sites. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences. Trial registration: The trial has been registered at the Chinese Clinical Trials Registry (ChiCTR2100044432).
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急性肾脏损伤的临床试验终点。
DOI：
10.1159/000363725
发表时间：
2014
期刊：
Nephron. Clinical practice
影响因子：
--
作者：
Billings FT 4th;Shaw AD
通讯作者：
Shaw AD
影响因子：
12.6
作者：
Wu, Bechien U.;Hwang, James Q.;Conwell, Darwin L.
通讯作者：
Conwell, Darwin L.
影响因子：
24.5
作者：
Schepers, Nicolien J.;Bakker, Olaf J.;Bruno, Marco J.
通讯作者：
Bruno, Marco J.
影响因子：
2.5
作者：
Zhou, Jiaojiao;Li, Yi;Fu, Ping
通讯作者：
Fu, Ping
DOI：
10.1056/nejmoa1711586
发表时间：
2018-03-01
期刊：
The New England journal of medicine
影响因子：
--
作者：
Self WH;Semler MW;Wanderer JP;Wang L;Byrne DW;Collins SP;Slovis CM;Lindsell CJ;Ehrenfeld JM;Siew ED;Shaw AD;Bernard GR;Rice TW;SALT-ED Investigators
通讯作者：
SALT-ED Investigators