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Completed

NCT Number: NCT03557957

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Centre Zagreb, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Targeted correction of plasma sodium levels

Other

Targeted correction of hyponatremia

Standard care

Other

Standard care of hyponatremia

Primary outcomes

  1. The primary outcome is the combined risk of death or rehospitalization within 30 days

    Time frame: 30 days

    Rate of death or rehospitalization within 30 days

Secondary outcomes

  1. 30 days mortality rate

    Time frame: 30 days

    Mortality rate

  2. 1 year mortality rate

    Time frame: 1 year

    Mortality rate

  3. 30 days rehospitalization rate

    Time frame: 30 days

    Rehospitalization rate

  4. 1 year rehospitalization rate

    Time frame: 1 year

    Rehospitalization rate

  5. Time to rehospitalization

    Time frame: up to 1 year

    Days until first rehospitalization

  6. Time to death

    Time frame: up to 1 year

    Days until death

  7. length of hospital stay

    Time frame: up to 1 year

    length of index hospital stay in days

  8. Rate of falls

    Time frame: 30 days

    Number of falls

  9. Rate of fractures

    Time frame: 30 days

    Number of bone fractures

  10. Rate of fractures

    Time frame: 1 year

    Number of bone fractures

  11. Rate of Plasma sodium normalization at discharge

    Time frame: up to 1 year

    Rate of Plasma sodium Levels >=135mmol/L at discharge

  12. Change in Plasma sodium Levels

    Time frame: up to 1 year

    Change in mmol/L in Plasma sodium Levels from inclusion to discharge

  13. Recurrence of hyponatremia

    Time frame: 30 days

    Rate of recurrence of hyponatremia

  14. Recurrence of hyponatremia

    Time frame: 1 year

    Rate of recurrence of hyponatremia

  15. Severely symptomatic hyponatremia

    Time frame: up to 1 year

    Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization

  16. Sodium-overcorrection

    Time frame: up to 1 year

    Rate of plasma sodium overcorrection during index hospitalization

  17. number of adverse events

    Time frame: 30 days

    Rate of adverse events

  18. number of adverse events

    Time frame: 1 year

    Rate of adverse events

  19. Severe adverse events

    Time frame: 30 days

    Rate of severe adverse events

  20. Severe adverse events

    Time frame: 1 year

    Rate of severe adverse events

  21. Diagnostic accuracy of copeptin in the diagnosis of hyponatremia

    Time frame: 1 day

    Copeptin Level will be correlated with final hyponatremia diagnosis

  22. Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia

    Time frame: 1 day

    MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)

  23. Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia

    Time frame: 1 day

    NT-proBNP Level will be correlated with final hyponatremia diagnosis

  24. Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia

    Time frame: 1 day

    Aldosterone Level will be correlated with final hyponatremia diagnosis

  25. Diagnostic accuracy of renin in the diagnosis of hyponatremia

    Time frame: 1 day

    Renin Level will be correlated with final hyponatremia diagnosis

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi
  • Cantonal Hospital of Aarau, Switzerland
  • Cantonal Hospital of St. Gallen
  • Erasmus Medical Center
  • KBC Zagreb, Croatia
  • Kantonsspital Liestal, Switzerland
  • Spital Solothurn, Switzerland
  • Universitätsklinikum Köln

Registry information

Official study title

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

Acronym: HIT

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2018
Registry last updated
Jul 11, 2025

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.

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