Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

Not Applicable

Completed

• Conditions: Hyponatremia

• Registration Number: NCT03557957
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Study Start: 2018-08-20
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2278

Inclusion Criteria

• All adult hospitalised patients with hypotonic hyponatremia <130mmol/L
• Hospitalization of at least 24 h after inclusion in the study

Exclusion Criteria

• severe symptomatic hyponatremia in need of intensive care treatment
• non-hypotonic hyponatremia with plasma osmolality >280 milliosmol (mOsm)/kg
• end of life care (palliative treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is the combined risk of death or rehospitalization within 30 days	30 days	Rate of death or rehospitalization within 30 days

Secondary Outcome Measures

Name	Time	Method
1 year mortality rate	1 year	Mortality rate
30 days rehospitalization rate	30 days	Rehospitalization rate
number of adverse events	1 year	Rate of adverse events
Rate of Plasma sodium normalization at discharge	up to 1 year	Rate of Plasma sodium Levels \>=135mmol/L at discharge
Change in Plasma sodium Levels	up to 1 year	Change in mmol/L in Plasma sodium Levels from inclusion to discharge
1 year rehospitalization rate	1 year	Rehospitalization rate
Time to rehospitalization	up to 1 year	Days until first rehospitalization
Time to death	up to 1 year	Days until death
length of hospital stay	up to 1 year	length of index hospital stay in days
Recurrence of hyponatremia	1 year	Rate of recurrence of hyponatremia
Diagnostic accuracy of renin in the diagnosis of hyponatremia	1 day	Renin Level will be correlated with final hyponatremia diagnosis
Rate of falls	30 days	Number of falls
Rate of fractures	1 year	Number of bone fractures
Severely symptomatic hyponatremia	up to 1 year	Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization
Severe adverse events	1 year	Rate of severe adverse events
Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia	1 day	Aldosterone Level will be correlated with final hyponatremia diagnosis
Sodium-overcorrection	up to 1 year	Rate of plasma sodium overcorrection during index hospitalization
Diagnostic accuracy of copeptin in the diagnosis of hyponatremia	1 day	Copeptin Level will be correlated with final hyponatremia diagnosis
Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia	1 day	MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)
Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia	1 day	NT-proBNP Level will be correlated with final hyponatremia diagnosis
30 days mortality rate	30 days	Mortality rate

Trial Locations

Locations (9)

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Uniklinik Köln; 🇩🇪 Köln, Germany

Careggi University Hospital Florence; 🇮🇹 Firenze, Italy

Erasmus Medical Center Rotterdam; 🇳🇱 Rotterdam, Netherlands

University Hospital Basel, Department of Endocrinology; 🇨🇭 Basel, Basel Stadt, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Kantonsspital Baselland; 🇨🇭 Liestal, Switzerland

Kantosspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Solothurner Spitäler AG; 🇨🇭 Solothurn, Switzerland