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Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia (HIT)

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ClinicalTrials.gov Identifier: NCT03557957
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
Erasmus Medical Center
Cantonal Hospital of Aarau, Switzerland
Luzerner Kantonsspital
Kantonsspital St. Gallen, Switzerland
Kantonsspital Liestal
St. Antonius Ziekenhuis Nieuwegein, The Netherlands
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hyponatremia Other: Targeted correction of plasma sodium levels Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, parallel-group trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to allocated treatment group
Primary Purpose: Treatment
Official Title: Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Standard care plus targeted correction of hyponatremia
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.
Other: Targeted correction of plasma sodium levels
Targeted correction of hyponatremia

Active Comparator: 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.
Other: Standard care
Standard care of hyponatremia




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557957


Contacts
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Contact: Mirjam Christ-Crain, Prof. MD +41 61 265 50 78 mirjam.christ@usb.ch
Contact: Julie Refardt, MD +41 61 328 76 08 julie.refardt@usb.ch

Locations
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Switzerland
University Hospital Basel, Department of Endocrinology Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Julie Refardt, Dr., MD    +41 61 328 76 08    julie.refardt@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Erasmus Medical Center
Cantonal Hospital of Aarau, Switzerland
Luzerner Kantonsspital
Kantonsspital St. Gallen, Switzerland
Kantonsspital Liestal
St. Antonius Ziekenhuis Nieuwegein, The Netherlands
Investigators
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Principal Investigator: Mirjam Christ-Crain, Prof. MD University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03557957    
Other Study ID Numbers: HIT-trial
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on the public repository dataverse.harvard.edu.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
URL: http://dataverse.harvard.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases