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Not yet recruiting NCT06498856

Saline Infusion Test in Hyponatremia

Observational Hyponatremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Isotonic saline infusion.
Who it may be relevant to
Registry conditions: Hyponatremia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Isotonic saline infusion
    Volume expansion with one liter of isotonic saline intravenously over two hours.

Primary outcome measures

  • Copeptin plasma levels [Time frame: 240 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06498856 · 23/12081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗