ECEESPE2025 Rapid Communications Rapid Communications 4: Pituitary, Neuroendocrinology and Puberty Part 1 (6 abstracts)
1Erasmus MC, Rotterdam, Netherlands; 2University Hospital Basel, Basel, Switzerland; 3University Hospital Cologne, Cologne, Germany; 4Kantonsspital Aarau, Aarau, Switzerland; 5Kantonsspital St. Gallen, St. Gallen, Switzerland; 6University Hospital Zagreb, Zagreb, Croatia; 7Careggi University Hospital, Firenze, Italy; 8Kantonsspital Solothurn, Solothurn, Switzerland
JOINT313
Background: Chronic hyponatremia is associated with increased mortality and rehospitalization rates, but it remains unclear whether this relationship is causal. The aim of this study was to evaluate the effects of targeted hyponatremia correction versus routine care on mortality and rehospitalization rates.
Methods: Pragmatic, randomized controlled, parallel-group, international multicenter trial with blinded outcome assessment. Hospitalized participants with plasma sodium <130 mmol/l from nine European centers were assigned to undergo either targeted correction of hyponatremia according to guidelines (intervention) or routine care for hyponatremia (control). The primary outcome was the combined risk of death or rehospitalization within 30 days of study inclusion.
Results: 2173 patients were included in the primary analysis of whom 1079 (49.7%) were randomized to the intervention and 1094 (50.3%) to the control group. Normonatremia was reached in 641 (60.4%) patients in the intervention group compared to 492 (46.2%) patients in the control group. Within 30 days after inclusion, the primary outcome occurred in 20.5% (218/1065 patients) in the intervention group and 21.8% (234/1073 patients) in the control group (estimated absolute difference in proportions [95% CI] -1.3% [-4.9, 2.2], P=0.45). Death occurred in 86 (8.0%) and rehospitalization in 141 (13.2%) patients in the intervention group compared to 88 (8.0%) and 151 (14.1%) patients in the control group. These findings were consistent in the per-protocol analysis and no evidence of effect modification was found for hyponatremia etiology and severity.
Conclusion: In hospitalized patients with chronic hyponatremia, targeted correction of plasma sodium did not reduce 30-day mortality and rehospitalization rates.
Trial registration
ClinicalTrials.gov (NCT03557957)