Ignite Creation Date:
2024-07-17 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Saline Infusion Test in Hyponatremia
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
Official Title:
Saline Infusion Test in Hyponatremia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
SITH
Brief Summary:
Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia
Detailed Description:
Hyponatremia low plasma sodium concentration is a common electrolyte disorder among hospitalized patients that can lead to complications such as gait instability falls and mental changes Both hyponatremia itself and overly rapid correction of hyponatremia may lead to brain damage
There are several underlying causes of hyponatremia that require different treatment strategies Specifically hypovolemia is treated with fluid infusion while other common causes such as the syndrome of inappropriate diuresis SIAD and hypervolemic conditions need fluid restriction In clinical practice it can be challenging to identify the main cause of hyponatremia due to overlapping diagnosis and unreliable diagnostic tools typically leading to a timely trial and error approach to therapy
A saline infusion test SIT is often used to diagnose hypovolemic hyponatremia To our knowledge the test has never been validated but relies on the rationale that the sodium concentration will increase more with saline infusion in hypovolemia than in other causes of hyponatremia Typically one liter of isotonic saline is infused intravenously and an arbitrarily set cut-off for sodium increase is used to indicate hypovolemia As the response of sodium depends on several factors that affects the renal free water excretion capacity this measure may not be the most accurate nor the most efficient Another more direct approach could be to measure the change in biochemical markers of circulating volume in response to the volume expansion that comes with saline infusion We will measure several different biomarkers before during and after a standardized isotonic saline infusion in patients hospitalized with hyponatremia Based on the results we hope to develop a more precise tool for the differential diagnosis of hyponatremia
There are several underlying causes of hyponatremia that require different treatment strategies Specifically hypovolemia is treated with fluid infusion while other common causes such as the syndrome of inappropriate diuresis SIAD and hypervolemic conditions need fluid restriction In clinical practice it can be challenging to identify the main cause of hyponatremia due to overlapping diagnosis and unreliable diagnostic tools typically leading to a timely trial and error approach to therapy
A saline infusion test SIT is often used to diagnose hypovolemic hyponatremia To our knowledge the test has never been validated but relies on the rationale that the sodium concentration will increase more with saline infusion in hypovolemia than in other causes of hyponatremia Typically one liter of isotonic saline is infused intravenously and an arbitrarily set cut-off for sodium increase is used to indicate hypovolemia As the response of sodium depends on several factors that affects the renal free water excretion capacity this measure may not be the most accurate nor the most efficient Another more direct approach could be to measure the change in biochemical markers of circulating volume in response to the volume expansion that comes with saline infusion We will measure several different biomarkers before during and after a standardized isotonic saline infusion in patients hospitalized with hyponatremia Based on the results we hope to develop a more precise tool for the differential diagnosis of hyponatremia
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