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Recruiting NCT05542056

NCT05542056 Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia

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Clinical Trial Summary
NCT ID NCT05542056
Status Recruiting
Phase
Sponsor University Hospital, Basel, Switzerland
Condition Thiazide-induced Hyponatremia (TIH)
Study Type OBSERVATIONAL
Enrollment 232 participants
Start Date 2022-09-26
Primary Completion 2026-07

Trial Parameters

Condition Thiazide-induced Hyponatremia (TIH)
Sponsor University Hospital, Basel, Switzerland
Study Type OBSERVATIONAL
Phase N/A
Enrollment 232
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-26
Completion 2026-07
Interventions
Data and biosample collection

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Brief Summary

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment.

Eligibility Criteria

Inclusion Criteria: * Newly prescribed thiazide or thiazide-like diuretic * ≥ 18 years of age * Informed Consent as documented by signature Exclusion Criteria: * Intake of thiazide or thiazide-like diuretic in the preceding month * Hyponatremia (plasma sodium \<135 mmol/L) at baseline * Acute infectious / inflammatory disease (CRP ≥ 20 mg/L \[1, 11\]) * Symptomatic urinary tract infection * Chronic treatment with NSAID and / or NSAID intake 48 hours prior to urine sampling at visit 1 and 2 (intake of acetylsalicylic acid will be no exclusion criteria) * End of life care, no informed consent or inability to follow the procedures of the study, e.g., due to language barriers, psychological disorders, dementia

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