Hyponatremia
Conditions
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.
Interventions
OTHERStandard care
Standard care of hyponatremia
OTHERTargeted correction of plasma sodium levels
Targeted correction of hyponatremia
Sponsors
Erasmus Medical Center
Cantonal Hospital of Aarau, Switzerland
Spital Solothurn, Switzerland
Cantonal Hospital of St. Gallen
Kantonsspital Liestal, Switzerland
Universitätsklinikum Köln
KBC Zagreb, Croatia
Azienda Ospedaliero-Universitaria Careggi
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to allocated treatment group
Intervention model description
Randomized, controlled, parallel-group trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 1 year mortality rate | 1 year | Mortality rate |
| 30 days rehospitalization rate | 30 days | Rehospitalization rate |
| 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 |
| Rate of falls | 30 days | Number of falls |
| Rate of fractures | 30 days | Number of bone fractures |
| 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 |
| 30 days mortality rate | 30 days | Mortality rate |
| Severely symptomatic hyponatremia | up to 1 year | Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization |
| Sodium-overcorrection | up to 1 year | Rate of plasma sodium overcorrection during index hospitalization |
| number of adverse events | 30 days | Rate of adverse events |
| Severe adverse events | 30 days | Rate of severe adverse events |
| 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 |
| Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia | 1 day | Aldosterone Level will be correlated with final hyponatremia diagnosis |
| Diagnostic accuracy of renin in the diagnosis of hyponatremia | 1 day | Renin Level will be correlated with final hyponatremia diagnosis |
| Recurrence of hyponatremia | 30 days | Rate of recurrence of hyponatremia |
Countries
Croatia, Germany, Italy, Netherlands, Switzerland
Outcome results
None listed