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NCT Number: NCT06013800

Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional B Veracruz Alta Especialidad

Veracruz, 91700, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Measurement of sodium levels

Other

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).

Primary outcomes

  1. Rate of participants with sodium level >135mEq/L

    Time frame: Baseline, everyday up to 30 days

    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.

Secondary outcomes

  1. Assessment of clinical variables associated with corrected sodium levels

    Time frame: Baseline, up to 30 days

    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.

Sponsors and collaborators

Lead sponsor

Universidad Veracruzana

Other

Registry information

Official study title

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

Acronym: Vostaus

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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