Clinical trial NCT03557957: Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia
Official title: Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Cantonal Hospital of Aarau, Switzerland
name: Spital Solothurn, Switzerland
name: Kantonsspital St. Gallen, Switzerland
name: Kantonsspital Liestal, Switzerland
name: Universitätsklinikum Köln
name: KBC Zagreb, Croatia
name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2018-06-15
Enrollment: 2278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel-group trial
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* All adult hospitalised patients with hypotonic hyponatremia \<130mmol/L

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)

Primary outcomes:
measure: The primary outcome is the combined risk of death or rehospitalization within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: 30 days mortality rate
timeFrame: 30 days
measure: 1 year mortality rate
timeFrame: 1 year
measure: 30 days rehospitalization rate
timeFrame: 30 days
measure: 1 year rehospitalization rate
timeFrame: 1 year
measure: Time to rehospitalization
timeFrame: up to 1 year
measure: Time to death
timeFrame: up to 1 year
measure: length of hospital stay
timeFrame: up to 1 year
measure: Rate of falls
timeFrame: 30 days
measure: Rate of fractures
timeFrame: 30 days
measure: Rate of fractures
timeFrame: 1 year
measure: Rate of Plasma sodium normalization at discharge
timeFrame: up to 1 year
measure: Change in Plasma sodium Levels
timeFrame: up to 1 year
measure: Recurrence of hyponatremia
timeFrame: 30 days
measure: Recurrence of hyponatremia
timeFrame: 1 year
measure: Severely symptomatic hyponatremia
timeFrame: up to 1 year
measure: Sodium-overcorrection
timeFrame: up to 1 year
measure: number of adverse events
timeFrame: 30 days
measure: number of adverse events
timeFrame: 1 year
measure: Severe adverse events
timeFrame: 30 days
measure: Severe adverse events
timeFrame: 1 year
measure: Diagnostic accuracy of copeptin in the diagnosis of hyponatremia
timeFrame: 1 day
measure: Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia
timeFrame: 1 day
measure: Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia
timeFrame: 1 day
measure: Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia
timeFrame: 1 day
measure: Diagnostic accuracy of renin in the diagnosis of hyponatremia
timeFrame: 1 day
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Köln
country: Germany
facility: Uniklinik Köln
city: Firenze
country: Italy
facility: Careggi University Hospital Florence
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Rotterdam
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Endocrinology
state: Basel Stadt
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Saint Gallen
country: Switzerland
facility: Kantosspital St. Gallen
city: Solothurn
country: Switzerland
facility: Solothurner Spitäler AG
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Refardt J, Pelouto A, Potasso L, Hoorn EJ, Christ-Crain M. Hyponatremia Intervention Trial (HIT): Study Protocol of a Randomized, Controlled, Parallel-Group Trial With Blinded Outcome Assessment. Front Med (Lausanne). 2021 Sep 6;8:729545. doi: 10.3389/fmed.2021.729545. eCollection 2021.