Hyponatremia Volume Status Analysis by Point-of-care Ultrasound (Vostaus)
Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Veracruz, Mexico, 91700
- Hospital Regional B Veracruz Alta Especialidad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Same Volume Status (Clinical and Point-of-Care Ultrasound)
The patient has the same volume status clinically and by point-of-care ultrasound
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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).
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Different Volume Status (Clinical or Point-of-Care Ultrasound)
The patient has a different volume status clinically or by point-of-care ultrasound
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of participants with sodium level >135mEq/L
Time Frame: Baseline, everyday up to 30 days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of clinical variables associated with corrected sodium levels
Time Frame: Baseline, up to 30 days
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To analyze whether the relationship between point-of-care ultrasound-assessed volume status and clinical variables-such as hypertonic saline administration, chronic liver disease, diuretic use, active cancer, type of hospital admission, severity of hyponatremia, and antidepressant use-influences corrected sodium levels.
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Baseline, up to 30 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alejandro Martínez Carreón, MD, Universidad Veracruzana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-93-254-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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