NCT Number: NCT06381934
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
Laura Potasso, Dr. med. sc.
CONTACT
Laura Potasso, Dr. med. sc.
PRINCIPAL_INVESTIGATOR
Mirjam Christ-Crain, Prof. Dr. med.
CONTACT
Mirjam Christ-Crain, Prof. Dr. med.
SUB_INVESTIGATOR
Thiazide or thiazide-like diuretics associated hyponatremia (thiazide associated hyponatremia, TAH) has a high prevalence in hospitalized patients. Patients might present either with a hypovolemic hyponatremia due to volume loss as a diuretic effect of thiazide, or with a syndrome of inadequate antidiuresis (SIAD) like hyponatremia in need of fluid restriction. Canonical urine indices are not useful in differential diagnosis, being directly influenced by thiazide itself. Current guidelines suggest the use of a clinical volume status assessment, but this approach has a poor diagnostic performance, with less than 50% of patients being rightly diagnosed thru that. The investigators showed in a retrospective analysis the possible role of strong apparent ion difference (aSID) and of chloride and potassium levels in urine (ChU) in differential diagnosis of TAH. The goal of this study is to investigate prospectively whether implementation of aSID and, in case of inconclusive aSID, ChU, allows a correct differential diagnosis and treatment of TAH.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard diagnosis and therapy procedures at physician's discretion.
Stopping of thiazide therapy. Measure aSID:
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.
Time frame: at baseline, 24 hours and up to 72 hours
Percentage of patients with an increase in serum sodium level > 4 mmol/l at day 1 or > 134 mmol/l in maximum 3 days in the aSID/ChU guided therapy group as compared to the standard care (control) group.
Time frame: at baseline, 24 hours and up to 72 hours
Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels.
Time frame: at baseline, 24 hours and up to 72 hours
Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels.
Time frame: at baseline, 24 hours and up to 72 hours
Sensibility, specificity, negative predictive value and positive predictive value at different cut-offs for adequate therapy of TAH. An adequate therapy of TAH is a therapy by which the patient reaches the primary endpoint independent from randomization arm.
Time frame: at baseline, 24 hours and up to 72 hours
Sensibility, specificity, negative predictive value and positive predictive value at different cut-offs for adequate therapy of TAH. An adequate therapy of TAH is a therapy by which the patient reaches the primary endpoint independent from randomization arm.
Time frame: at baseline, 24 hours and up to 72 hours
Sensibility, specificity, negative predictive value and positive predictive value at different cut-offs for adequate therapy of TAH. An adequate therapy of TAH is a therapy by which the patient reaches the primary endpoint independent from randomization arm.
Time frame: at baseline, 24 hours and up to 72 hours
Sensibility, specificity, negative predictive value and positive predictive value at different cut-offs for adequate therapy of TAH. An adequate therapy of TAH is a therapy by which the patient reaches the primary endpoint independent from randomization arm.
Time frame: at baseline, 24 hours and up to 72 hours
Sensibility, specificity, negative predictive value and positive predictive value at different cut-offs for adequate therapy of TAH. An adequate therapy of TAH is a therapy by which the patient reaches the primary endpoint independent from randomization arm.
Contact information is provided by the study sponsor or research team.
University Hospital, Basel, Switzerland
Other
Validation of Diagnostic Indices to Simplify Hyponatremia Therapy Assessment - A Randomized, Controlled, Parallel-group Clinical Trial in Hospitalized Patients on Thiazide Diuretics (THAT Study)
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