Vostaus: Hyponatremia Volume Status Analysis by Point-of-care Ultrasound

Sponsor

Universidad Veracruzana (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06013800

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyponatremia Water-Electrolyte Imbalance	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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

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

Rate of participants with overcorrection of sodium [Baseline, everyday up to 30 days]
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.
All cause mortality [Baseline, everyday up to 30 days]
Rate of death of participants in group 1 and group 2 within 30 days
Length of stay [Baseline, everyday up to 30 days]
Length of index hospital stay in days up to 30 days in group 1 and group 2.
Incidence of additional treatment [Baseline, everyday up to 48 hours]
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)
Determination of risk factors associated with additional treatment [Baseline, everyday up to 48 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).