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Saline Infusion Test in Hyponatremia

Saline Infusion Test in Hyponatremia

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06498856
Acronym
SITH
Enrollment
100
Registered
2024-07-12
Start date
2024-07-31
Completion date
2028-12-31
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

Arginine vasopressin, Copeptin, Antidiuretic hormone, Saline infusion test, Fluid- and volume regulation, Renin, Aldosterone

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.

Interventions

Volume expansion with one liter of isotonic saline intravenously over two hours.

Sponsors

Hormone Laboratory, Aker University Hospital, Oslo, Norway
CollaboratorOTHER
University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Plasma sodium 120-130 mmol/L * Effective osmolality (2 x plasma sodium + plasma glucose) \< 275 milliosmol/L * Age \> 18 years

Exclusion criteria

* Intensive care unit (ICU) admission * Adequate sodium correction rate: \> 4 mmol/L last 24 hours * Primary polydipsia: urine osmolality \< 100 mOsm/L * Hypertonic saline therapy * Adrenal insufficiency * Severe heart failure: ejection fraction \< 35 % or clinical suspicion of decompensated heart failure * Ascites grade 3 (marked abdominal distention and discomfort) * Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \< 30 * Failure to submit informed consent

Design outcomes

Primary

MeasureTime frameDescription
Copeptin plasma levels240 minutesChanges in copeptin levels in response to isotonic saline infusion

Contacts

Primary ContactKaja Grønning, MD
Kaja.Gronning@ahus.no67960000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026