An observational study in Hyponatremia, sponsored by University Hospital, Akershus. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by University Hospital, Akershus · Observational
Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.
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.
155 studies on the registry are indexed under Hyponatremia; 17 are open to participants now.
This study's planned enrollment of 100 is below the median of 180 across 57 observational studies indexed under Hyponatremia.
Browse Hyponatremia studies →University Hospital, Akershus is the lead sponsor of 123 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to hospital with hyponatremia.
Exclusion Criteria:
Patients admitted to hospital with hypo-osmolar hyponatremia with uncertain primary cause. Eligible patients will receive a standardized intravenous infusion of isotonic saline.
Other: Isotonic saline infusion
Volume expansion with one liter of isotonic saline intravenously over two hours.
Copeptin plasma levels
Changes in copeptin levels in response to isotonic saline infusion
Time frame: 240 minutes
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Akershus