Validation of Diagnostic Indices to Simplify Hyponatremia Therapy Assessment - A Randomized, Controlled, Parallel-group Clinical Trial in Hospitalized Patients on Thiazide Diuretics (THAT Study)
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 \< 130 mmol/l and serum osmolality \< 300 mOsm/kg
• with treatment with thiazide or thiazide-like diuretic
Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Laura Potasso, Dr. med. sc.
laura.potasso@usb.ch
+41 61 328 58 76
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2027-04
Participants
Target number of participants: 136
Treatments
Active_comparator: Standard Care Group
TAH patients randomised to the Standard Care Group will be followed by a physician not involved in the study.
Active_comparator: aSID/ChU Guided Therapy Group
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland