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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Group | Active Comparator | TAH patients randomised to the Standard Care Group will be followed by a physician not involved in the study. |
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| aSID/ChU Guided Therapy Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Other | Standard diagnosis and therapy procedures at physician's discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Sodium Level | 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. | at baseline, 24 hours and up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels | Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels. | at baseline, 24 hours and up to 72 hours |
| Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Potasso, Dr. med. sc. | Contact | +41 61 328 58 76 | laura.potasso@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Laura Potasso, Dr. med. sc. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40646556 | Derived | 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. |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| aSID/ChU Guided Therapy | Other | 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. |
|
Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels. |
| at baseline, 24 hours and up to 72 hours |
| Diagnostic performance analyses of: aSID and ChU | 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. | at baseline, 24 hours and up to 72 hours |
| Diagnostic performance analyses of: aSID measured in blood gas analysis | 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. | at baseline, 24 hours and up to 72 hours |
| Diagnostic performance analyses of: clinical volume status assessment | 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. | at baseline, 24 hours and up to 72 hours |
| Diagnostic performance analyses of: not-invasive instrumental volume status assessment | 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. | at baseline, 24 hours and up to 72 hours |
| Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin | 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. | at baseline, 24 hours and up to 72 hours |