Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Validation of Diagnostic Indices to Simplify Hyponatremia Therapy Assessment - A Randomized, Controlled, Parallel-group Clinical Trial in Hospitalized Patients on Thiazide Diuretics (THAT Study)
University Hospital, Basel, Switzerland
136 participants
May 6, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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).
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Interventions
Standard diagnosis and therapy procedures at physician's discretion.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06381934