Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on T… (NCT06381934) | Clinical Trial Compass
RecruitingNot Applicable
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Switzerland136 participantsStarted 2024-05-06
Plain-language summary
This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments.
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:
* Hospitalized patients presenting at University Hospital Basel
* aged 18 years or older
* able to give informed consent as documented by signature
* with serum sodium level \< 133 mmol/l and serum osmolality \< 300 mOsm/kg
* with treatment with thiazide or thiazide-like diuretic
Exclusion Criteria:
* symptomatic hyponatremia in need of 3% hypertonic solution or intensive care treatment
* inability or contraindications to undergo the trial (i.e., any acute severe cardiovascular event requiring an immediate intervention)
* decompensated liver cirrhosis CHILD C
* decompensated heart failure NYHA III or higher
* severe valve impairment
* untreated adrenal insufficiency
* severe kidney disease in need of dialysis
* pregnancy or breastfeeding
* end of life care
* inability to follow the study procedures (i.e., language problem, dementia or critical illness).
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
1
Serum Sodium Level
Timeframe: at baseline, 24 hours and up to 72 hours