Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

Study Overview
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Brief Summary
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This observational study aims to analyze the time of correction of hyponatremia in patients within an internal medicine ward. The researchers will assess volume status using both clinical evaluation and point-of-care ultrasound. Patients will be categorized based on whether they have the same volume status determined clinically and by ultrasound or a different status between the two methods. By tracking sodium levels daily until normalization, the study will compare the time of hyponatremia correction between the two groups.

Detailed Description
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The main question it aims to answer are ¿What is the time of correction of hyponatremia by assessing the volume status clinically or by point of care of ultrasound?. Participants will be asked to participate in the study and they will be receive a volume status by a portable ultrasound. If they have the same volume status clinically and by point of care ultrasound they will be referred as group 1. If they have a different volume status clinically or by point of care ultrasound they will be referred as group 2. Researchers will follow the patients by measuring the sodium levels daily until they reach normal sodium levels ( >135mEq/L) and will compare group 1 and group 2 with a survival analysis.

Official Title
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Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine

Conditions
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Water-Electrolyte Imbalance, Hyponatremia

Intervention / Treatment
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* Other: Measurement of sodium levels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater or equal to 18 years Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18) Exclusion Criteria: Patients who are critically ill with ventilatory support. Patients with clinical signs suggestive of hypovolemia and have a documented history of aortic insufficiency or show mitral insufficiency during POCUS (Point-of-Care Ultrasound).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Same Volume Status (Clinical and Point-of-Care Ultrasound)<br>The patient has the same volume status clinically and by point-of-care ultrasound | Other: Measurement of sodium levels<br>* Patients will get measurements of sodium levels daily in the first 48 hours, then daily or every other day until normal sodium levels (>135mEq/L).<br>|
| Different Volume Status (Clinical or Point-of-Care Ultrasound)<br>The patient has a different volume status clinically or by point-of-care ultrasound | Other: Measurement of sodium levels<br>* Patients will get measurements of sodium levels daily in the first 48 hours, then daily or every other day until normal sodium levels (>135mEq/L).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with sodium level >135mEq/L | Rate of Achieving a Normal Sodium Level (>135mEq/L) per Participant: This information will be visually represented through Group 1 and Group 2 using a Kaplan-Meier curve. Subsequently, the data will be evaluated using the Log-Rank test or the Breslow test for statistical significance. | Baseline, everyday up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with overcorrection of sodium | This refers to participants who experienced daily corrections greater than 8mEq/L or 18mEq/L in 48 hours. Rate of Sodium Overcorrection in Group 1 and Group 2 within 30 Days. | Baseline, everyday up to 30 days | 
| All cause mortality | Rate of death of participants in group 1 and group 2 within 30 days | Baseline, everyday up to 30 days | 
| Length of stay | Length of index hospital stay in days up to 30 days in group 1 and group 2. | Baseline, everyday up to 30 days | 
| Incidence of additional treatment | Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours) | Baseline, everyday up to 48 hours | 
| Determination of risk factors associated with additional treatment | Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours). patients who received 3% hypertonic saline and <3% hypertonic saline, patients with ascites due to liver disease, patients with gastrointestinal losses and diuretic use, patients with gastrointestinal losses and chronic kidney disease, patients over 65 years and using antidepressants, patients with active cancer, patients with pneumonia, patients with exacerbation of Chronic Obstructive Pulmonary Disease, patients with sodium levels <125mEq/L, patients with traumatic brain injury and patients with cerebrovascular disease | Baseline, everyday up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyponatremia, water-electrolyte imbalance, POCUS, Point-of-care ultrasound