Tolvaptan vs Fluid Restriction in Moderate-Profound Hyponatremia: An Open-Label Randomized Clinical Trial
Authors' conclusion
Tolvaptan was superior to FR at raising pNa over 3 days. However, intervention was required to prevent overcorrection in some, with no benefit in secondary outcomes. This is the first prospectively validated protocol to detect and prevent tolvaptan-related overcorrection.
Study context
- Population
- Hospitalised patients with pNa 115 to 130 mmol/L (mean 124 mmol/L), single-centre tertiary hospital, Melbourne, Australiarandomized 1:1
- Participants
- 54 patients
- Comparison
- Tolvaptan vs fluid restriction
- Primary endpoint
- Plasma sodium change from day 1 to 4 (main outcome measures also included IV 5% dextrose requirement for overcorrection, symptoms and LOS)
- Follow-up
- Day 1 to 4
Methodological detailsopen-label, single-centre
- Open-label
- Single-centre
Primary result
As reported in the abstract
Plasma sodium (pNa) change · over 3 days
Each group vs FREstimate (95% CI)
Tolvaptan
mean adjusted difference (day 2) 3.2 mmol/L(1.6–4.7)
Tolvaptan
mean adjusted difference (day 3) 3.5 mmol/L(1.9–5.2)
Tolvaptan
mean adjusted difference (day 4) 2.5 mmol/L(0.8–4.2)
Secondary outcomes
- No difference in LOS or symptoms
Safety
- Dextrose 5% required to treat rapid sodium increase — Tolvaptan
- 19%
Na increase >10 mmol/L at 24 hours
- Patients with Na increase >10 mmol/L at 24 h (with dextrose intervention)
- 0
Original publication
Tolvaptan vs Fluid Restriction in Moderate-Profound Hyponatremia: An Open-Label Randomized Clinical Trial. J Clin Endocrinol Metab. Published 28 July 2025. doi:10.
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