CompletedNot Applicable

Hypotonic Hyponatremia: Criteria for the Correct Classification of Its Etiology and of Patient Volume Status

Italy123 participantsStarted 2018-06-01

Plain-language summary

Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice. The patient approach, however, is still problematic, above all because hyponatremia is a manifestation correlated to various pathological conditions, with complex etiopathogenesis. Even though some algorithms have been proposed to correctly assess hyponatremia subtype classification and patient volume status, there is no single parameter that has proven to be able alone to perfectly achieve this result.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Access to the emergency department (ED) of our hospital from Monday to Thursday, between 8 am and 6 pm (time constraint needed so that all the necessary laboratory analyzes could be correctly completed) * Detection at the time of ED access of moderate-severe hyponatremia, defined as serum sodium \< 130 mmol/L at blood gas analysis (BGA) * Need for hospitalization Exclusion Criteria: * Programmed hospitalization that did not include access through the ED

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subtype classification of hypotonic hyponatremia according to the overall judgment of the clinical case by the point-of-care clinician

Timeframe: At ED admission

Subtype classification of hypotonic hyponatremia according to the overall judgment of the clinical case by the point-of-care clinician

Timeframe: At hospital ward admission

Physical Examination (PE) as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At ED admission

Physical Examination (PE) as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At hospital ward admission

Inferior Vena Cava (IVC) ultrasound evaluation as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At ED admission

Inferior Vena Cava (IVC) ultrasound evaluation as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At hospital ward admission

Trial details

NCT IDNCT04402190

SponsorA.O.U. Città della Salute e della Scienza

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Hyponatremia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Subtype classification of hypotonic hyponatremia according to the overall judgment of the clinical case by the point-of-care clinician

Timeframe: At ED admission

Subtype classification of hypotonic hyponatremia according to the overall judgment of the clinical case by the point-of-care clinician

Timeframe: At hospital ward admission

Physical Examination (PE) as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At ED admission

Physical Examination (PE) as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At hospital ward admission

Inferior Vena Cava (IVC) ultrasound evaluation as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At ED admission

Inferior Vena Cava (IVC) ultrasound evaluation as a tool for the assessment of Extra-Cellular Fluid (ECF) Volume Status

Timeframe: At hospital ward admission