An interventional study of Targeted correction of plasma sodium levels and Standard care in Hyponatremia, sponsored by University Hospital, Basel, Switzerland. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
155 studies on the registry are indexed under Hyponatremia; 17 are open to participants now.
This study's enrollment of 2,278 is above the median of 58 across 92 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnosis and treatment of hyponatremia will be standardized according to the European Clinical Practice Guidelines (ECPG). Treatment response and adherence will be evaluated daily and treatment adapted if treatment goals are not reached.Targeted correction of plasma sodium Levels.
Other: Targeted correction of plasma sodium levels
Diagnosis and treatment of hyponatremia will be solely at the discretion of the attending physicians who are in no way involved in the trial. The study team will not intervene with the treatment in any way. Diagnostic and treatment decisions as well as course of the plasma sodium level will only be recorded after patient is discharged from hospital using the medical records and patient charts. It will be generally recommended to measure plasma sodium levels 3x weekly or more frequently if clinically indicated, at discharge and after 30 days.
Other: Standard care
Targeted correction of hyponatremia
Standard care of hyponatremia
The primary outcome is the combined risk of death or rehospitalization within 30 days
Rate of death or rehospitalization within 30 days
Time frame: 30 days
30 days mortality rate
Mortality rate
Time frame: 30 days
1 year mortality rate
Mortality rate
Time frame: 1 year
30 days rehospitalization rate
Rehospitalization rate
Time frame: 30 days
1 year rehospitalization rate
Rehospitalization rate
Time frame: 1 year
Time to rehospitalization
Days until first rehospitalization
Time frame: up to 1 year
Time to death
Days until death
Time frame: up to 1 year
length of hospital stay
length of index hospital stay in days
Time frame: up to 1 year
Rate of falls
Number of falls
Time frame: 30 days
Rate of fractures
Number of bone fractures
Time frame: 30 days
Rate of fractures
Number of bone fractures
Time frame: 1 year
Rate of Plasma sodium normalization at discharge
Rate of Plasma sodium Levels \>=135mmol/L at discharge
Time frame: up to 1 year
Change in Plasma sodium Levels
Change in mmol/L in Plasma sodium Levels from inclusion to discharge
Time frame: up to 1 year
Recurrence of hyponatremia
Rate of recurrence of hyponatremia
Time frame: 30 days
Recurrence of hyponatremia
Rate of recurrence of hyponatremia
Time frame: 1 year
Severely symptomatic hyponatremia
Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization
Time frame: up to 1 year
Sodium-overcorrection
Rate of plasma sodium overcorrection during index hospitalization
Time frame: up to 1 year
number of adverse events
Rate of adverse events
Time frame: 30 days
number of adverse events
Rate of adverse events
Time frame: 1 year
Severe adverse events
Rate of severe adverse events
Time frame: 30 days
Severe adverse events
Rate of severe adverse events
Time frame: 1 year
Diagnostic accuracy of copeptin in the diagnosis of hyponatremia
Copeptin Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia
MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)
Time frame: 1 day
Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia
NT-proBNP Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia
Aldosterone Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Diagnostic accuracy of renin in the diagnosis of hyponatremia
Renin Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Plan to share: Yes — Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on the public repository dataverse.harvard.edu.
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland