Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

Hyponatremia Clinical Trial

— HIT  

Official title:

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03557957
• Other study ID #: HIT-trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2278
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Other:
• Targeted correction of plasma sodium levels
Targeted correction of hyponatremia
• Standard care
Standard care of hyponatremia

Locations

Country	Name	City	State
Croatia	University Hospital Centre Zagreb	Zagreb
Germany	Uniklinik Köln	Köln
Italy	Careggi University Hospital Florence	Firenze
Netherlands	Erasmus Medical Center Rotterdam	Rotterdam
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	University Hospital Basel, Department of Endocrinology	Basel	Basel Stadt
Switzerland	Kantonsspital Baselland	Liestal
Switzerland	Kantosspital St. Gallen	Saint Gallen
Switzerland	Solothurner Spitäler AG	Solothurn

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Azienda Ospedaliero Universitaria Careggi, Italy, Cantonal Hospital of Aarau, Switzerland, Erasmus Medical Center, Kantonsspital Liestal, Switzerland, Kantonsspital St. Gallen, Switzerland, KBC Zagreb, Croatia, Spital Solothurn, Switzerland, Uniklinik Köln, Germany

Countries where clinical trial is conducted

Croatia,  Germany,  Italy,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the combined risk of death or rehospitalization within 30 days	Rate of death or rehospitalization within 30 days	30 days
Secondary	30 days mortality rate	Mortality rate	30 days
Secondary	1 year mortality rate	Mortality rate	1 year
Secondary	30 days rehospitalization rate	Rehospitalization rate	30 days
Secondary	1 year rehospitalization rate	Rehospitalization rate	1 year
Secondary	Time to rehospitalization	Days until first rehospitalization	up to 1 year
Secondary	Time to death	Days until death	up to 1 year
Secondary	length of hospital stay	length of index hospital stay in days	up to 1 year
Secondary	Rate of falls	Number of falls	30 days
Secondary	Rate of fractures	Number of bone fractures	30 days
Secondary	Rate of fractures	Number of bone fractures	1 year
Secondary	Rate of Plasma sodium normalization at discharge	Rate of Plasma sodium Levels >=135mmol/L at discharge	up to 1 year
Secondary	Change in Plasma sodium Levels	Change in mmol/L in Plasma sodium Levels from inclusion to discharge	up to 1 year
Secondary	Recurrence of hyponatremia	Rate of recurrence of hyponatremia	30 days
Secondary	Recurrence of hyponatremia	Rate of recurrence of hyponatremia	1 year
Secondary	Severely symptomatic hyponatremia	Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization	up to 1 year
Secondary	Sodium-overcorrection	Rate of plasma sodium overcorrection during index hospitalization	up to 1 year
Secondary	number of adverse events	Rate of adverse events	30 days
Secondary	number of adverse events	Rate of adverse events	1 year
Secondary	Severe adverse events	Rate of severe adverse events	30 days
Secondary	Severe adverse events	Rate of severe adverse events	1 year
Secondary	Diagnostic accuracy of copeptin in the diagnosis of hyponatremia	Copeptin Level will be correlated with final hyponatremia diagnosis	1 day
Secondary	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)	1 day
Secondary	Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia	NT-proBNP Level will be correlated with final hyponatremia diagnosis	1 day
Secondary	Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia	Aldosterone Level will be correlated with final hyponatremia diagnosis	1 day
Secondary	Diagnostic accuracy of renin in the diagnosis of hyponatremia	Renin Level will be correlated with final hyponatremia diagnosis	1 day