Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

Active, not recruiting

• Conditions: Hyponatremia; Water-Electrolyte Imbalance
• Interventions: Other: Measurement of sodium levels

• Registration Number: NCT06013800
• Lead Sponsor: Universidad Veracruzana

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.

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-28
• Study Start: 2023-10-01
• Primary Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-19
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Same Volume Status (Clinical and Point-of-Care Ultrasound)	Measurement of sodium levels	The patient has the same volume status clinically and by point-of-care ultrasound
Different Volume Status (Clinical or Point-of-Care Ultrasound)	Measurement of sodium levels	The patient has a different volume status clinically or by point-of-care ultrasound

Primary Outcome Measures

Name	Time	Method
Rate of participants with sodium level >135mEq/L	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 Outcome Measures

Name	Time	Method
Assessment of clinical variables associated with corrected sodium levels	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.

Trial Locations

Locations (1)

Hospital Regional B Veracruz Alta Especialidad; 🇲🇽 Veracruz, Mexico