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Not yet recruitingNCT06498856SITHUpdated Jul 12, 2024

Saline Infusion Test in Hyponatremia

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

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

Read the 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.

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Conditions studied

  • Hyponatremia

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Keywords

  • Arginine vasopressin
  • Copeptin
  • Antidiuretic hormone
  • Saline infusion test
  • Fluid- and volume regulation
  • Renin
  • Aldosterone
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In context

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients admitted to hospital with hyponatremia.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adult patients with hypoosmolar hyponatremia

    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

Interventions

  • OtherIsotonic saline infusion

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

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What researchers measure

Primary outcomes

  1. Copeptin plasma levels

    Changes in copeptin levels in response to isotonic saline infusion

    Time frame: 240 minutes

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06498856
Lead sponsor
University Hospital, Akershus
Collaborators
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Responsible party
Jacob Winther, MD, PhD (Head of Endocrinology department, University Hospital, Akershus) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 2024 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 12, 2024

Study contacts

Kaja Grønning, MD
Contact
Kaja.Gronning@ahus.no
67960000
Jacob A Winther, MD,PHD
study director · University Hospital, Akershus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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