• Lu Ke, Bo Ye, Mingfeng Huang, Tao Chen, Gordon Doig, Chao Li, Yingjie Chen, Hongwei Zhang, Lijuan Zhao, Guobing Chen, Shumin Tu, Long Fu, Honghai Xia, Dongliang Yang, Bin Wu, Baohua Ye, Guoxiu Zhang, Mei Yang, Qiang Li, Xiaomei Chen, Xinting Pan, Wenjian Mao, James Buxbaum, Samir Jaber, Zhihui Tong, Yuxiu Liu, John Windsor, Rinaldo Bellomo, Weiqin Li, and Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG).
• Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.
• Ann. Surg. 2024 May 6.

ObjectiveTo compare the effect of balanced multielectrolyte solutions(BMES) versus normal saline(NS) for intravenous fluid on chloride levels and clinical outcomes.in patients with predicted severe acute pancreatitis (pSAP).Summary Background DataIsotonic crystalloids are recommended for initial fluid therapy in acute pancreatitis, but whether the use of BMES in preference to NS confers clinical benefits is unknown.MethodsIn this multicenter, stepped-wedge, cluster-randomized trial, we enrolled patients with pSAP (APACHE II score ≥8 and C-reactive protein >150 mg/L) admitted within 72 hours of the advent of symptoms. The study sites were randomly assigned to staggered start dates for one-way crossover from the NS phase (NS for intravenous fluid) to the BMES phase(Sterofudin for intravenous fluid). The primary endpoint was the serum chloride concentration on trial day3. Secondary endpoints included a composite of clinical and laboratory measures.ResultsOverall, 259 patients were enrolled from eleven sites to receive NS(n=147) or BMES(n=112). On trial day3, the mean chloride level was significantly lower in patients who received BMES(101.8 mmol/L(SD4.8) versus 105.8 mmol/L(SD5.9), difference -4.3 mmol/L [95%CI -5.6 to -3.0 mmol/L];P<0.001). For secondary endpoints, patients who received BMES had less systemic inflammatory response syndrome(19/112,17.0% versus 43/147,29.3%, P=0.024) and increased organ failure-free days (3.9 d(SD2.7) versus 3.5days(SD2.7), P<0.001) by trial day7. They also spent more time alive and out of ICU(26.4 d(SD5.2) versus 25.0days(SD6.4), P=0.009) and hospital(19.8 d(SD6.1) versus16.3days(SD7.2), P<0.001) by trial day30.ConclusionsAmong patients with pSAP, using BMES in preference to NS resulted in a significantly more physiological serum chloride level, which was associated with multiple clinical benefits(Trial registration number: ChiCTR2100044432).Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.

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