Open-label randomized controlled study of salt-restricted vs salt-unrestricted diet in patients with cirrhosis with hyponatremia
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: World Journal of Methodology
Institution: All India Institute of Medical Sciences, Patna
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7155214560