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Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06013800
Acronym
Vostaus
Enrollment
80
Registered
2023-08-28
Start date
2023-10-01
Completion date
2024-12-31
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, Water-Electrolyte Imbalance

Keywords

hyponatremia, water-electrolyte imbalance, POCUS, Point-of-care ultrasound

Brief summary

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

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.

Interventions

OTHERMeasurement of sodium levels

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).

Sponsors

Universidad Veracruzana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Rate of participants with sodium level >135mEq/LBaseline, everyday up to 30 daysRate 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.

Secondary

MeasureTime frameDescription
Assessment of clinical variables associated with corrected sodium levelsBaseline, up to 30 daysTo 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026