Hyponatremia Clinical Trial
— VostausOfficial title:
Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Regional B Veracruz Alta Especialidad | Veracruz |
Lead Sponsor | Collaborator |
---|---|
Universidad Veracruzana |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | All cause mortality | Rate of death of participants in group 1 and group 2 within 30 days | Baseline, everyday up to 30 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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