NCT03557957

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,278 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. While treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. Accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge. This is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. Yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality. The aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.

Conditions

• Hyponatremia

Interventions

Type	Name	Description
OTHER	Targeted correction of plasma sodium levels	Targeted correction of hyponatremia
OTHER	Standard care	Standard care of hyponatremia

Timeline

• Start date: 2018-08-20
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2018-06-15
• Last updated: 2025-07-11

Locations

9 sites across 5 countries: Croatia, Germany, Italy, Netherlands, Switzerland