Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381934
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-16
Brief Title:
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None