Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/35318
Title: Balanced Solution versus Normal Saline in Predicted Severe Acute Pancreatitis: A Stepped Wedge Cluster Randomized Trial.
Austin Authors: Ke, Lu;Ye, Bo;Huang, Mingfeng;Chen, Tao;Doig, Gordon;Li, Chao;Chen, Yingjie;Zhang, Hongwei;Zhao, Lijuan;Chen, Guobing;Tu, Shumin;Fu, Long;Xia, Honghai;Yang, Dongliang;Wu, Bin;Ye, Baohua;Zhang, Guoxiu;Yang, Mei;Li, Qiang;Chen, Xiaomei;Pan, Xinting;Mao, Wenjian;Buxbaum, James;Jaber, Samir;Tong, Zhihui;Liu, Yuxiu;Windsor, John;Bellomo, Rinaldo ;Li, Weiqin
Affiliation: Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.;National Institute of Healthcare Data Science, Nanjing University, Nanjing 210010, Jiangsu, China.
Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.
Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.
Department of Public Health, Policy and Systems, Institute of Population Health, Whelan Building, Quadrangle, The University of Liverpool, Liverpool, L69 3GB, UK.
Northern Clinical School Intensive Care Research Unit, University of Sydney, Sydney, NSW, Australia.
Department of Epidemiology and Health Statistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an 710061, China.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan, China.
Department of Critical Care Medicine, Jinjiang Hospital of Traditional Chinese Medicine, Jinjiang 362200, Fujian, China.
Department of Emergency, The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China.
Department of Emergency, Shangqiu First People's Hospital, Shangqiu 476000, Henan, China.
Department of Emergency, The First Affiliated Hospital of the University of Science and Technology of China, Hefei, Anhui, China.
Department of Intensive Care Unit, The first affiliated hospital of Xiamen University (Tongan Branch), Xiamen, Fujian, China.
Department of Intensive Care Unit, The Qujing NO.1 People's Hospital, Qujing, Yunnan, China.
Pancreas Center, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China; Pancreas Institute, Nanjing Medical University, Nanjing 210029, Jiangsu, China.
Department of Critical Care Medicine, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250012, Shandong, China.
Department of Emergency Intensive Care Unit, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.
Department of Medicine, Division of Gastroenterology, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.
Anesthesia and Critical Care Department (DAR-B), Saint Eloi, University of Montpellier, Research Unit: PhyMedExp, INSERM U-1046, CNRS, 34295 Montpellier, Cedex 5, France.
Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.
Intensive Care
Surgical and Translational Research Centre, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1142, New Zealand.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Department of Critical Care, The University of Melbourne, Parkville, Victoria, Australia; Department of Intensive Care, Austin Hospital, Heidelberg, Victoria, Australia; Data Analytics Research and Evaluation Centre, Austin Hospital, Melbourne, Australia; Department of Critical Care, Royal Melbourne Hospital, Melbourne, Australia.
Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing 210002, Jiangsu, China.;National Institute of Healthcare Data Science, Nanjing University, Nanjing 210010, Jiangsu, China.
Data Analytics Research and Evaluation (DARE) Centre
Issue Date: 6-May-2024
Date: 2024
Publication information: Annals of Surgery 2024-05-06
Abstract: To 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). Isotonic 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. In 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. Overall, 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. Among 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).
URI: https://ahro.austin.org.au/austinjspui/handle/1/35318
DOI: 10.1097/SLA.0000000000006319
ORCID: 
Journal: Annals of surgery
PubMed URL: 38708888
ISSN: 1528-1140
Type: Journal Article
Appears in Collections:Journal articles

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