HyponatremiaSITHNCT06498856
Saline Infusion Test in Hyponatremia
An observational study of Hyponatremia, run by University Hospital, Akershus.
Trial summary
Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Isotonic saline infusion
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to hospital with hyponatremia.
Who may be able to join
- Plasma sodium 120-130 mmol/L
- Effective osmolality (2 x plasma sodium + plasma glucose) < 275 milliosmol/L
- Age > 18 years
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Hyponatremia
- Being tested
- Isotonic saline infusion
- Keywords
- Arginine vasopressin, Copeptin, Antidiuretic hormone, Saline infusion test, Fluid- and volume regulation, Renin, Aldosterone
- Medical subject headings
- Hyponatremia, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic saline infusionOther
Volume expansion with one liter of isotonic saline intravenously over two hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Isotonic saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copeptin plasma levels
Changes in copeptin levels in response to isotonic saline infusion
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Responsible party
- Principal investigator, Jacob Winther, MD, PhD, University Hospital, Akershus
- Investigators
- Jacob A Winther, MD,PHD, Study director, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498856
- Sponsor's protocol ID
- 23/12081
- Acronym
- SITH
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline Infusion Test in Hyponatremia
- ClinicalTrials.gov ID
- NCT06498856
- Acronym / sponsor ID
- SITH / 23/12081
- Conditions
- Hyponatremia
- Keywords
- Arginine vasopressin, Copeptin, Antidiuretic hormone, Saline infusion test, Fluid- and volume regulation, Renin, Aldosterone
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with hypoosmolar hyponatremia | – | Other: Isotonic saline infusionPatients admitted to hospital with hypo-osmolar hyponatremia with uncertain primary cause. Eligible patients will receive a standardized intravenous infusion of isotonic saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital with hyponatremia.
Key inclusion criteria (3 listed)
- Plasma sodium 120-130 mmol/L
- Effective osmolality (2 x plasma sodium + plasma glucose) < 275 milliosmol/L
- Age > 18 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isotonic saline infusionVolume expansion with one liter of isotonic saline intravenously over two hours. | Other | Adult patients with hypoosmolar hyponatremia |
Primary outcome
Copeptin plasma levels
Time frame: 240 minutes
Changes in copeptin levels in response to isotonic saline infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
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Recruiting
Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics
Thiazide Associated Hyponatremia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob A Winther, MD,PHD study director
University Hospital, Akershus
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by University Hospital, Akershus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaja Grønning, MD (67960000, Kaja.Gronning@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copeptin plasma levels (time frame: 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.