Marrapu S, Kumar R, Bhushan D, Kumar S, Kumar A, Priyadarshi RN, Anand U. Open-label randomized controlled study of salt-restricted vs salt-unrestricted diet in patients with cirrhosis with hyponatremia. World J Methodol 2026; 16(2): 112692 [DOI: 10.5662/wjm.v16.i2.112692]
Corresponding Author of This Article
Ramesh Kumar, MD, Professor, DM, Head, Department of Gastroenterology, All India Institute of Medical Sciences, Phulwari Sharif, Patna 801507, India. docrameshkr@gmail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Clinical Trial
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
Jun 20, 2026 (publication date) through Apr 23, 2026
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Journal Information of This Article
Publication Name
World Journal of Methodology
ISSN
2222-0682
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Marrapu S, Kumar R, Bhushan D, Kumar S, Kumar A, Priyadarshi RN, Anand U. Open-label randomized controlled study of salt-restricted vs salt-unrestricted diet in patients with cirrhosis with hyponatremia. World J Methodol 2026; 16(2): 112692 [DOI: 10.5662/wjm.v16.i2.112692]
Sudheer Marrapu, Ramesh Kumar, Sudhir Kumar, Abhishek Kumar, Department of Gastroenterology, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Divendu Bhushan, Department of Emergency Medicine, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Rajeev N Priyadarshi, Department of Radiodiagnosis, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Utpal Anand, Department of Surgical Gastroenterology, All India Institute of Medical Sciences, Patna 801507, Bihar, India
Author contributions: Marrapu S and Kumar R designed the study, analyzed the data, and drafted the manuscript; Bhushan D, Kumar S, and Kumar A collected the data and contributed to the writing of the manuscript; Priyadarshi RN and Anand U assisted with the data collection and reviewed the manuscript; All authors approved the final version.
Institutional review board statement: The study protocol was approved by the Institutional Ethics Committee (No. AIIMS/Pat/IEC/PGT/Jan23-06) and conducted in accordance with the Declaration of Helsinki.
Informed consent statement: Informed consent for the study and publication was obtained from each patient included in this study.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
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:
Supporting data are available in a standard proforma and Microsoft Excel spreadsheet, and will be provided upon receipt of a valid and appropriate request.
Corresponding author: Ramesh Kumar, MD, Professor, DM, Head, Department of Gastroenterology, All India Institute of Medical Sciences, Phulwari Sharif, Patna 801507, India. docrameshkr@gmail.com
Received: August 4, 2025 Revised: August 22, 2025 Accepted: January 9, 2026 Published online: June 20, 2026 Processing time: 263 Days and 18.4 Hours
Abstract
BACKGROUND
Salt restriction is commonly recommended for patients with cirrhosis to manage ascites; however, its safety and efficacy in patients with hyponatremia remain unclear.
AIM
To evaluate the effects of a salt-restricted diet (SRD; 5 g/day) vs a salt-unrestricted diet (SUD; 10 g/day) on renal, nutritional, and hemodynamic outcomes, as well as short-term mortality in patients with cirrhosis with moderate to severe hyponatremia.
METHODS
A total of 150 patients with serum sodium < 130 mEq/L were randomized to either SRD or SUD. After excluding patients who died, were non-adherent, or were lost to follow-up within 4 weeks, 105 participants (SRD: 51; SUD: 54) were included in the outcomes analysis. The primary outcome was the incidence of acute kidney injury (AKI) over 6 months; secondary outcomes included ascites control, nutritional markers, and mortality.
RESULTS
Baseline characteristics were largely comparable. AKI occurred in 45 patients (42.8%), which was significantly more in the SRD group (58.8% vs 27.7%; P = 0.005). SRD was an independent predictor of AKI (odds ratio: 4.85), and the risk of AKI was 66% lower in the SUD group (hazard ratio: 0.34; P < 0.001). While ascites control was numerically better in the SUD group, the difference was not statistically significant. The SUD group exhibited better hemodynamic and nutritional indices, including mean arterial pressure, mid-arm circumference, handgrip strength, and serum albumin. Mortality was significantly lower in the SUD group (29.6% vs 54.9%; P = 0.009), and survival analysis consistently favored SUD.
CONCLUSION
Salt restriction in patients with cirrhosis with moderate to severe hyponatremia may predispose them to renal dysfunction, nutritional decline, and increased short-term mortality without providing a clear benefit in ascites control. These findings underscore the need for individualized sodium recommendations in patients with advanced cirrhosis.
Core Tip: This study highlights the potential harm of salt restriction in patients with cirrhosis with moderate to severe hyponatremia. Patients in the salt-restricted diet group (5 g/day) had significantly higher risk of acute kidney injury, poorer nutritional and hemodynamic profiles, and increased short-term mortality compared to those in the salt-unrestricted diet group (10 g/day). Importantly, no significant improvement in ascites control was observed with salt restriction. These results question the routine use of salt restriction in this subgroup and emphasize the need for a more tailored dietary approach to optimize renal function, nutrition, and survival outcomes in patients with hyponatremic cirrhosis.
