HyponatremiaVostausNCT06013800
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
An observational study of Hyponatremia and Water-Electrolyte Imbalance, run by Universidad Veracruzana at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Water-Electrolyte Imbalance
- What is being tested?
- Measurement of sodium levels
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2023to Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypotonic hyponatremia
Who may be able to join
- Age greater or equal to 18 years
- Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyponatremia, Water-Electrolyte Imbalance
- Being tested
- Measurement of sodium levels
- Keywords
- hyponatremia, water-electrolyte imbalance, POCUS, Point-of-care ultrasound
- Medical subject headings
- Hyponatremia, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of sodium levelsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Same Volume Status (Clinical and Point-of-Care Ultrasound) | The patient has the same volume status clinically and by point-of-care ultrasound Receives: Other: Measurement of sodium levels | |
| Different Volume Status (Clinical or Point-of-Care Ultrasound) | The patient has a different volume status clinically or by point-of-care ultrasound Receives: Other: Measurement of sodium levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, everyday up to 30 days
Secondary outcomes (1)
Assessment of clinical variables associated with corrected sodium levels
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.
Measured: Baseline, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Veracruzana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Martínez Carreón, Universidad Veracruzana
- Investigators
- Alejandro Martínez Carreón, MD, Principal investigator, Universidad Veracruzana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013800
- Sponsor's protocol ID
- 01-93-254-2023
- Acronym
- Vostaus
- Status last verified
- Nov 2024
- First submitted
- 11 Aug 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine
- ClinicalTrials.gov ID
- NCT06013800
- Acronym / sponsor ID
- Vostaus / 01-93-254-2023
- Conditions
- Hyponatremia, Water-Electrolyte Imbalance
- Keywords
- hyponatremia, water-electrolyte imbalance, POCUS, Point-of-care ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad VeracruzanaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same Volume Status (Clinical and Point-of-Care Ultrasound) | – | Other: Measurement of sodium levelsThe patient has the same volume status clinically and by point-of-care ultrasound |
| Different Volume Status (Clinical or Point-of-Care Ultrasound) | – | Other: Measurement of sodium levelsThe patient has a different volume status clinically or by point-of-care ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypotonic hyponatremia
Key inclusion criteria (2 listed)
- Age greater or equal to 18 years
- Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of sodium levelsPatients will get measurements of sodium levels daily in the first 48 hours, then daily or every other day until normal sodium levels (>135mEq/L). | Other | Different Volume Status (Clinical or Point-of-Care Ultrasound), Same Volume Status (Clinical and Point-of-Care Ultrasound) |
Primary outcome
Rate of participants with sodium level >135mEq/L
Time frame: 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.
1 secondary outcome
Assessment of clinical variables associated with corrected sodium levels
Time frame: Baseline, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Related trials for Hyponatremia
RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
Recruiting
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Thiazide Associated Hyponatremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Martínez Carreón, MD principal investigator
Universidad Veracruzana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Water-Electrolyte Imbalance, run by Universidad Veracruzana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with sodium level >135mEq/L (time frame: Baseline, everyday up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.