Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
NCT ID: NCT06381934
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
136 participants
INTERVENTIONAL
2024-05-06
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Care Group
TAH patients randomised to the Standard Care Group will be followed by a physician not involved in the study.
Standard Care
Standard diagnosis and therapy procedures at physician's discretion.
aSID/ChU Guided Therapy Group
TAH patients randomised to the aSID/ChU Guided Therapy Group will have aSID and ChU determined and, depending on the results, will be assigned to fluid administration with saline or drinking restriction.
aSID/ChU Guided Therapy
Stopping of thiazide therapy. Measure aSID:
* aSID between 39 and 42 mmol/l : measure ChU
* ChU lower than 15mmol/l : fluid administration (0.9% NaCl infusion, 250-500 ml over 2 hours followed by 10-20 ml/kg/24h)
* ChU higher than 14.9 mmol/l : drinking restriction (of at least 50% of usual drinking volume)
* aSID higher than 42 mmol/l : fuid administration (fluid administration (0.9% NaCl infusion, 250-500 ml over 2 hours followed by 10-20 ml/kg/24h)
* aSID lower than 39 mmol/l : drinking restriction (of at least 50% of usual drinking volume)
The aSID/ChU guided therapy will take place for a minimum of 1- and a maximum of 3 days after enrolment. Treatment and adherence to the treatment will be assessed and re-evaluated at least daily for 3 days or till discharge or sodium normalization.
Interventions
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Standard Care
Standard diagnosis and therapy procedures at physician's discretion.
aSID/ChU Guided Therapy
Stopping of thiazide therapy. Measure aSID:
* aSID between 39 and 42 mmol/l : measure ChU
* ChU lower than 15mmol/l : fluid administration (0.9% NaCl infusion, 250-500 ml over 2 hours followed by 10-20 ml/kg/24h)
* ChU higher than 14.9 mmol/l : drinking restriction (of at least 50% of usual drinking volume)
* aSID higher than 42 mmol/l : fuid administration (fluid administration (0.9% NaCl infusion, 250-500 ml over 2 hours followed by 10-20 ml/kg/24h)
* aSID lower than 39 mmol/l : drinking restriction (of at least 50% of usual drinking volume)
The aSID/ChU guided therapy will take place for a minimum of 1- and a maximum of 3 days after enrolment. Treatment and adherence to the treatment will be assessed and re-evaluated at least daily for 3 days or till discharge or sodium normalization.
Eligibility Criteria
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Inclusion Criteria
* aged 18 years or older
* able to give informed consent as documented by signature
* with serum sodium level \< 130 mmol/l and serum osmolality \< 300 mOsm/kg
* with treatment with thiazide or thiazide-like diuretic
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Laura Potasso, Dr. med. sc.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Vogt K, Widmer D, Kirsch M, Christ-Crain M, Potasso L. Validation of new diagnostic indices to simplify hyponatremia therapy assessment in patients on thiazide diuretics: study protocol of a randomized, controlled, parallel-group trial (THAT-Study). Trials. 2025 Jul 11;26(1):242. doi: 10.1186/s13063-025-08925-4.
Other Identifiers
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2024-00335; kt23ChristCrain4
Identifier Type: -
Identifier Source: org_study_id