Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

NCT06013800 | Active Not Recruiting

• 1 other identifier: 01-93-254-2023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia; Water-Electrolyte Imbalance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of clinical variables associated with corrected sodium levels

  Baseline, up to 30 days

Study Arms (2)

Same Volume Status (Clinical and Point-of-Care Ultrasound)

The patient has the same volume status clinically and by point-of-care ultrasound

Other: Measurement of sodium levels

Different Volume Status (Clinical or Point-of-Care Ultrasound)

The patient has a different volume status clinically or by point-of-care ultrasound

Other: Measurement of sodium levels

Interventions

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).

Different Volume Status (Clinical or Point-of-Care Ultrasound); Same Volume Status (Clinical and Point-of-Care Ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypotonic hyponatremia

You may qualify if:

• Age greater or equal to 18 years
• Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Veracruzana: lead

Study Sites (1)

Hospital Regional B Veracruz Alta Especialidad

Veracruz, 91700, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hyponatremia; Water-Electrolyte Imbalance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alejandro Martínez Carreón, MD

  Universidad Veracruzana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 28, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

ME (1)