Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

NCT ID: NCT06013800

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Hyponatremia Water-Electrolyte Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Measurement of sodium levels

Intervention Type 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)

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

Measurement of sodium levels

Intervention Type 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).

Interventions

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Measurement 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).

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Veracruzana

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Martínez Carreón

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro Martínez Carreón, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Veracruzana

Locations

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Hospital Regional B Veracruz Alta Especialidad

Veracruz, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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01-93-254-2023

Identifier Type: -

Identifier Source: org_study_id

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