Hyponatremia Volume Status Analysis by Point-of-care Ultrasound (Vostaus)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyponatremia; Water-Electrolyte Imbalance
• Intervention / Treatment: Other: Measurement of sodium levels

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Alejandro Martínez Carreón, MD; Phone Number: +522291611685; Email: alejandromtc23@hotmail.com

Study Locations

• Mexico
  • Veracruz, Mexico, 91700
    • Recruiting
    • Hospital Regional B Veracruz Alta Especialidad
    • Contact: Alejandro Martinez Carreon, MD; Phone Number: +52 2291611685; Email: alejandromtc23@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypotonic hyponatremia

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of participants with overcorrection of sodium	This refers to participants who experienced daily corrections greater than 8mEq/L or 18mEq/L in 48 hours. Rate of Sodium Overcorrection in Group 1 and Group 2 within 30 Days.	Baseline, everyday up to 30 days
All cause mortality	Rate of death of participants in group 1 and group 2 within 30 days	Baseline, everyday up to 30 days
Length of stay	Length of index hospital stay in days up to 30 days in group 1 and group 2.	Baseline, everyday up to 30 days
Incidence of additional treatment	Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours)	Baseline, everyday up to 48 hours
Determination of risk factors associated with additional treatment	Additional treatment is performed if symptom is not relieved or undercorrection develops (achieved Na < 5mmol/L with 24 hours or achieved Na <12mmol/L within 48 hours). patients who received 3% hypertonic saline and <3% hypertonic saline, patients with ascites due to liver disease, patients with gastrointestinal losses and diuretic use, patients with gastrointestinal losses and chronic kidney disease, patients over 65 years and using antidepressants, patients with active cancer, patients with pneumonia, patients with exacerbation of Chronic Obstructive Pulmonary Disease, patients with sodium levels <125mEq/L, patients with traumatic brain injury and patients with cerebrovascular disease	Baseline, everyday up to 48 hours

Collaborators and Investigators

• Sponsor: Universidad Veracruzana
• Investigators: Principal Investigator: Alejandro Martínez Carreón, MD, Universidad Veracruzana

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: hyponatremia; Point-of-care ultrasound; POCUS; water-electrolyte imbalance
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyponatremia; Water-Electrolyte Imbalance
• Other Study ID Numbers: 01-93-254-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No