Targeted correction of plasma sodium levels
OtherTargeted correction of hyponatremia
NCT Number: NCT03557957
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
University Hospital Centre Zagreb, Zagreb, Croatia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Targeted correction of hyponatremia
Standard care of hyponatremia
Time frame: 30 days
Rate of death or rehospitalization within 30 days
Time frame: 30 days
Mortality rate
Time frame: 1 year
Mortality rate
Time frame: 30 days
Rehospitalization rate
Time frame: 1 year
Rehospitalization rate
Time frame: up to 1 year
Days until first rehospitalization
Time frame: up to 1 year
Days until death
Time frame: up to 1 year
length of index hospital stay in days
Time frame: 30 days
Number of falls
Time frame: 30 days
Number of bone fractures
Time frame: 1 year
Number of bone fractures
Time frame: up to 1 year
Rate of Plasma sodium Levels >=135mmol/L at discharge
Time frame: up to 1 year
Change in mmol/L in Plasma sodium Levels from inclusion to discharge
Time frame: 30 days
Rate of recurrence of hyponatremia
Time frame: 1 year
Rate of recurrence of hyponatremia
Time frame: up to 1 year
Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization
Time frame: up to 1 year
Rate of plasma sodium overcorrection during index hospitalization
Time frame: 30 days
Rate of adverse events
Time frame: 1 year
Rate of adverse events
Time frame: 30 days
Rate of severe adverse events
Time frame: 1 year
Rate of severe adverse events
Time frame: 1 day
Copeptin Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)
Time frame: 1 day
NT-proBNP Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Aldosterone Level will be correlated with final hyponatremia diagnosis
Time frame: 1 day
Renin Level will be correlated with final hyponatremia diagnosis
University Hospital, Basel, Switzerland
Other
Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial
Acronym: HIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00201994
Brain Diseases, Cardiovascular Diseases
Gustav Carus, Dresden, Germany
View Trial DetailsNCT06781710
Demyelinating Diseases, Hyponatremia
Cologne, Germany
View Trial DetailsNCT01212211
Hyponatremia, Metabolic Diseases
Carentan, France
View Trial DetailsNCT07255833
Arrhythmias, Cardiac, Cardiovascular Diseases
Cologne, Germany
View Trial Details