Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia
- Conditions
- Hyponatremia
- Interventions
- Other: Standard careOther: Targeted correction of plasma sodium levels
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2278
- All adult hospitalised patients with hypotonic hyponatremia <130mmol/L
- 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
- Arm && Interventions
Group Intervention Description Standard care Standard care 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. Standard care plus targeted correction of hyponatremia Targeted correction of plasma sodium levels 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.
- 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
30 days mortality rate 30 days Mortality 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
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
Trial Locations
- Locations (9)
University Hospital Centre Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Uniklinik Köln
🇩🇪Köln, Germany
Erasmus Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
Careggi University Hospital Florence
🇮🇹Firenze, Italy
University Hospital Basel, Department of Endocrinology
🇨ðŸ‡Basel, Basel Stadt, Switzerland
Kantonsspital Baselland
🇨ðŸ‡Liestal, Switzerland
Solothurner Spitäler AG
🇨ðŸ‡Solothurn, Switzerland
Kantosspital St. Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Kantonsspital Aarau
🇨ðŸ‡Aarau, Switzerland