Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia: a Prospective Cohort Study (The PROPHECY Study)
University Hospital, Basel, Switzerland
232 participants
Sep 26, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- Newly prescribed thiazide or thiazide-like diuretic
- ≥ 18 years of age
- Informed Consent as documented by signature
Exclusion Criteria5
- 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
- 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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Interventions
Collection of spot urine, blood sampling, vital parameters, body weight, medical history, patient questionnaires, drinking protocol, drug diary at at Visit 1 (before thiazide initiation), at Optional 2 hours-challenge, at Visit 2 (4 weeks after thiazide initiation), at Visit 2.1 (4 weeks after dose change), at Visit 3 (3-months after thiazide initiation)
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05542056