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

Primary Purpose

Hyponatremia

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Targeted correction of plasma sodium levels
Standard care
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyponatremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Basel, Department of EndocrinologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standard care plus targeted correction of hyponatremia

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2018
Last Updated
November 1, 2022
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Erasmus Medical Center, Cantonal Hospital of Aarau, Switzerland, Spital Solothurn, Switzerland, Kantonsspital St. Gallen, Switzerland, Kantonsspital Liestal, Switzerland, Uniklinik Köln, Germany, KBC Zagreb, Croatia, Azienda Ospedaliero Universitaria Careggi, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03557957
Brief Title
Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia
Acronym
HIT
Official Title
Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Erasmus Medical Center, Cantonal Hospital of Aarau, Switzerland, Spital Solothurn, Switzerland, Kantonsspital St. Gallen, Switzerland, Kantonsspital Liestal, Switzerland, Uniklinik Köln, Germany, KBC Zagreb, Croatia, Azienda Ospedaliero Universitaria Careggi, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, parallel-group trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to allocated treatment group
Allocation
Randomized
Enrollment
2278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care plus targeted correction of hyponatremia
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Targeted correction of plasma sodium levels
Intervention Description
Targeted correction of hyponatremia
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care of hyponatremia
Primary Outcome Measure Information:
Title
The primary outcome is the combined risk of death or rehospitalization within 30 days
Description
Rate of death or rehospitalization within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30 days mortality rate
Description
Mortality rate
Time Frame
30 days
Title
1 year mortality rate
Description
Mortality rate
Time Frame
1 year
Title
30 days rehospitalization rate
Description
Rehospitalization rate
Time Frame
30 days
Title
1 year rehospitalization rate
Description
Rehospitalization rate
Time Frame
1 year
Title
Time to rehospitalization
Description
Days until first rehospitalization
Time Frame
up to 1 year
Title
Time to death
Description
Days until death
Time Frame
up to 1 year
Title
length of hospital stay
Description
length of index hospital stay in days
Time Frame
up to 1 year
Title
Rate of falls
Description
Number of falls
Time Frame
30 days
Title
Rate of fractures
Description
Number of bone fractures
Time Frame
30 days
Title
Rate of fractures
Description
Number of bone fractures
Time Frame
1 year
Title
Rate of Plasma sodium normalization at discharge
Description
Rate of Plasma sodium Levels >=135mmol/L at discharge
Time Frame
up to 1 year
Title
Change in Plasma sodium Levels
Description
Change in mmol/L in Plasma sodium Levels from inclusion to discharge
Time Frame
up to 1 year
Title
Recurrence of hyponatremia
Description
Rate of recurrence of hyponatremia
Time Frame
30 days
Title
Recurrence of hyponatremia
Description
Rate of recurrence of hyponatremia
Time Frame
1 year
Title
Severely symptomatic hyponatremia
Description
Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization
Time Frame
up to 1 year
Title
Sodium-overcorrection
Description
Rate of plasma sodium overcorrection during index hospitalization
Time Frame
up to 1 year
Title
number of adverse events
Description
Rate of adverse events
Time Frame
30 days
Title
number of adverse events
Description
Rate of adverse events
Time Frame
1 year
Title
Severe adverse events
Description
Rate of severe adverse events
Time Frame
30 days
Title
Severe adverse events
Description
Rate of severe adverse events
Time Frame
1 year
Title
Diagnostic accuracy of copeptin in the diagnosis of hyponatremia
Description
Copeptin Level will be correlated with final hyponatremia diagnosis
Time Frame
1 day
Title
Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia
Description
MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)
Time Frame
1 day
Title
Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia
Description
NT-proBNP Level will be correlated with final hyponatremia diagnosis
Time Frame
1 day
Title
Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia
Description
Aldosterone Level will be correlated with final hyponatremia diagnosis
Time Frame
1 day
Title
Diagnostic accuracy of renin in the diagnosis of hyponatremia
Description
Renin Level will be correlated with final hyponatremia diagnosis
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirjam Christ-Crain, Prof. MD
Phone
+41 61 265 50 78
Email
mirjam.christ@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Refardt, MD
Phone
+41 61 328 76 08
Email
julie.refardt@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, Prof. MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Department of Endocrinology
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Refardt, Dr., MD
Phone
+41 61 328 76 08
Email
julie.refardt@usb.ch

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
http://dataverse.harvard.edu
Citations:
PubMed Identifier
34552947
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.
Results Reference
derived

Learn more about this trial

Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia

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