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

Neurological Complications Associated With Serum Sodium ≤110 mmol/L and Its Treatment: An International Multi-Centre Retrospective Study.

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07576036

Acronym

PRONATREOUS

Enrollment

800

Registered

2026-05-08

Start date

2023-11-01

Completion date

2026-06-30

Last updated

2026-05-08

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

Conditions

Cerebral Edema, Hyponatremia Symptomatic, Osmotic Demyelination Syndrome

Keywords

Treatment and outcome of severe hyponatremia

Brief 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 demyelination syndrome (ODS) and outcomes including suspected and MRI-confirmed ODS, in-hospital death, and imaging confirmation of cerebral edema

Interventions

DRUGHypertonic 3% saline

Rapid Correction of hyponatremia

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Serum sodium ≤110 mmol/L at admission to the hospital

Exclusion criteria

* Blood glucose \>15 mmol/L, spurious laboratory dataa

Design outcomes

Primary

Measure	Time frame	Description
Osmotic demyelination syndrome	1 to 14 days	Neurological deterioration after treatment of hyponatremia
MRI-confirmed Osmotic Demyelination Syndrome	Within 30 days	Post treatment neurological deterioration with CPM and/or EPM

Secondary

Measure	Time frame	Description
Cerebral edema	2 days	Cerebral edema documented by imaging or death or respiratory arrest from suspected cerebral edema

Countries

United States

Contacts

STUDY_CHAIRRichard H Sterns, MD

University of Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026