Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

Hyponatremia Clinical Trial

— Vostaus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013800
• Other study ID #: 01-93-254-2023
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2023
• Source: Universidad Veracruzana
• Contact: Alejandro Martínez Carreón, MD
• Phone: +522291611685
• Email: alejandromtc23[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hyponatremia
• Water-Electrolyte Imbalance

Intervention

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).

Locations

Country	Name	City	State
Mexico	Hospital Regional B Veracruz Alta Especialidad	Veracruz

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Veracruzana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All cause mortality	Rate of death of participants in group 1 and group 2 within 30 days	Baseline, everyday up to 30 days
Secondary	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
Secondary	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
Secondary	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