Hyponatremia SymptomaticPRONATREOUSNCT07576036
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
An observational study of Hyponatremia Symptomatic and Osmotic Demyelination Syndrome, run by Rochester General Hospital at 1 site in United States.
Trial summary
Electronic medical records dating back as far as available for each center to identify patients admitted to the hospital with a serum sodium ≤110 mmol/l. Data on patient demographics, presenting symptoms, vital signs, laboratory findings, treatment given, sodium correction rates, presence of risk factors for osmotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia Symptomatic, Osmotic Demyelination Syndrome, Cerebral Edema
- What is being tested?
- Hypertonic 3% saline
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18 or higher with serum sodium ≤110 mmol/L
Who may be able to join
- Serum sodium ≤110 mmol/L at admission to the hospital
Who cannot join
- Blood glucose >15 mmol/L, spurious laboratory dataa
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Neurological Complications Associated With Serum Sodium ≤110 mmol/L and Its Treatment: An International Multi-Centre Retrospective Study.
Electronic medical records dating back as far as available for each center to identify patients admitted to the hospital with a serum sodium ≤110 mmol/l. Data on patient demographics, presenting symptoms, vital signs, laboratory findings, treatment given, sodium correction rates, presence of risk factors for osmotic demyelination syndrome (ODS) and outcomes including suspected and MRI-confirmed ODS, in-hospital death, and imaging confirmation of cerebral edema
- Being tested
- Hypertonic 3% saline
- Keywords
- Treatment and outcome of severe hyponatremia
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic 3% salineDrug
Also called Desmopressin, 5% dextrose in water
Rapid Correction of hyponatremia
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected or MRI-confirmed ODS | Patients without suspected or MRI-confirmed ODS Receives: Drug: Hypertonic 3% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osmotic demyelination syndrome
Neurological deterioration after treatment of hyponatremia
Measured: 1 to 14 days
MRI-confirmed Osmotic Demyelination Syndrome
Post treatment neurological deterioration with CPM and/or EPM
Measured: Within 30 days
Secondary outcomes (1)
Cerebral edema
Cerebral edema documented by imaging or death or respiratory arrest from suspected cerebral edema
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Nov 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyponatremia SymptomaticStudies 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
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- Richard H Sterns, MD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576036
- Sponsor's protocol ID
- 3042A PRONATREOUS
- Acronym
- PRONATREOUS
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Serum sodium values, outcomes and correction rates
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Complications Associated With Serum Sodium ≤110 mmol/L and Its Treatment: An International Multi-Centre Retrospective Study.
- ClinicalTrials.gov ID
- NCT07576036
- Acronym / sponsor ID
- PRONATREOUS / 3042A PRONATREOUS
- Keywords
- Treatment and outcome of severe hyponatremia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Rochester General HospitalUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 May 2026 (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.
Electronic medical records dating back as far as available for each center to identify patients admitted to the hospital with a serum sodium ≤110 mmol/l. Data on patient demographics, presenting symptoms, vital signs, laboratory findings, treatment given, sodium correction rates, presence of risk factors for osmotic demyelination syndrome (ODS) and outcomes including suspected and MRI-confirmed ODS, in-hospital death, and imaging confirmation of cerebral edema
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected or MRI-confirmed ODS | – | Drug: Hypertonic 3% salinePatients without suspected or MRI-confirmed ODS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18 or higher with serum sodium ≤110 mmol/L
Key inclusion criteria (1 listed)
- Serum sodium ≤110 mmol/L at admission to the hospital
Key exclusion criteria (1 listed)
- Blood glucose >15 mmol/L, spurious laboratory dataa
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 |
|---|---|---|
| Hypertonic 3% salineAlso: Desmopressin, 5% dextrose in waterRapid Correction of hyponatremia | Drug | Patients with suspected or MRI-confirmed ODS |
Primary outcome
Osmotic demyelination syndrome
Time frame: 1 to 14 days
Neurological deterioration after treatment of hyponatremia
MRI-confirmed Osmotic Demyelination Syndrome
Time frame: Within 30 days
Post treatment neurological deterioration with CPM and/or EPM
1 secondary outcome
Cerebral edema
Time frame: 2 days
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Serum sodium values, outcomes and correction rates
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.
Richard H Sterns, MD study chair
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia Symptomatic and Osmotic Demyelination Syndrome, run by Rochester General Hospital at 1 site in United States.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osmotic demyelination syndrome (time frame: 1 to 14 days). The study lists 2 primary outcomes in all. 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 26 Aug 2026.