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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Oct 27, 2025; 17(10): 110247
Published online Oct 27, 2025. doi: 10.4254/wjh.v17.i10.110247
Published online Oct 27, 2025. doi: 10.4254/wjh.v17.i10.110247
Effect of empagliflozin on fractional excretion of sodium in patients with cirrhosis and refractory ascites
Yuan Gao, Han-Lu You, Hou Wei, Zhong-Jie Hu, Department of Liver Disease Center, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China
Yun-Yi Gao, Department of Safe Transfusion Laboratory, Beijing Red Cross Blood Center, Beijing 100088, China
Rong-Ya Shi, Department of Liver Disease Center, Baoding People’s Hospital, Baoding 071000, Hebei Province, China
Dong Ji, Senior Department of Hepatology, Chinese PLA General Hospital, Beijing 100039, China
Yu Wang, Department of Liver Research Center, National Clinical Research Center of Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
Liang Xu, Department of Hepatology, Tianjin Second People’s Hospital, Tianjin 300192, China
Qi Wang, Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
Meng-Hua Wu, Department of Urology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
Qiu-Shi Bu, Xin-Yu Zhang, Academy of Mathematics and Systems Science, Chinese Academy of Sciences, Beijing 100190, China
Yi-Xi Dong, School of Management, University of Science and Technology of China, Hefei 201315, Anhui Province, China
Long-Zhen Zhou, College of Teachers, Columbia University, New York, NY 10041, United States
Wei Liu, Department of Pharmacy, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China
Qing-Kun Song, Department of Clinical Epidemiology and Biobank, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China
Ying Han, Department of Gastroenterology and Hepatology, Beijing You’an Hospital, Capital Medical University, Beijing 100069, China
Co-first authors: Yuan Gao and Yun-Yi Gao.
Co-corresponding authors: Xin-Yu Zhang and Zhong-Jie Hu.
Author contributions: Gao Y and Gao YY drafted the initial manuscript and they are contributed equally to this manuscript and are co-first authors; Gao Y, Gao YY, and Hu ZJ designed the study; Wu MH, You HL, Liu W, Song QK, Han Y, and Wei H conceived the study and participated in its design and coordination; Shi RY, Ji D, Wang Y, Xu L, and Wang Q adapted the protocol to Chinese local conditions and selected the study sites; Bu QS, Dong YX, Zhou LZ, and Zhang XY formed the independent statistical team for the study; Zhang XY was responsible for data processing; Zhang XY and Hu ZJ contributed equally to this manuscript and are corresponding authors. All authors approved the final manuscript.
Supported by Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support, No. ZLRK202533; High-Level Public Health Technology Talent Project, No. 2022-2-005; and the Scientific Research Project of Beijing You’an Hospital, 2024, No. BJYAYY-YN2022-20.
Institutional review board statement: The protocol has been approved by the Ethics Committee of Beijing You’an Hospital, Capital Medical University, No. LL-2024-151-K.
Clinical trial registration statement: This study has been registered in the Chinese Clinical Trial Registry, No. ChiCTR2500095222.
Informed consent statement: Written informed consent was obtained from all participants prior to enrollment. Each participant (or legally authorized representative, where applicable) received a detailed explanation of the study purpose, procedures, potential risks and benefits, and their right to withdraw at any time. The consent process complied with the Declaration of Helsinki and with local regulatory requirements.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Datasets will be available to all study investigators, according to a strict data sharing agreement. Data sharing will be available online for 6 months after the publication of the findings. Investigators may request access to the trial data by submitting a formal application to Beijing You’an Hospital, Capital Medical University. Data access will be governed by the principal investigators and subject to approval by the Trial Steering Committee.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zhong-Jie Hu, MD, Chief Physician, Professor, Senior Researcher, Senior Scientist, Department of Liver Disease Center, Beijing You’an Hospital, Capital Medical University, No. 8 Xitoutiao outside You’anmen, Fengtai District, Beijing 100069, China. yfcyt@139.com
Received: June 4, 2025
Revised: July 9, 2025
Accepted: September 19, 2025
Published online: October 27, 2025
Processing time: 147 Days and 4.8 Hours
Revised: July 9, 2025
Accepted: September 19, 2025
Published online: October 27, 2025
Processing time: 147 Days and 4.8 Hours
Core Tip
Core Tip: Refractory ascites reflects proximal tubular sodium retention and frequent diuretic resistance in cirrhosis. We present a multicenter randomized protocol testing empagliflozin, a sodium-glucose co-transporter 2 inhibitor that promotes proximal tubular natriuresis without renin-angiotensin-aldosterone system stimulation, for refractory cirrhotic ascites. The trial compares empagliflozin plus standard care versus standard care over 14 days. Primary endpoint is change in fractional excretion of sodium; secondary outcomes include 24-hour urinary sodium, urine volume, ascites by ultrasound, body weight, and prespecified clinical safety parameters.