Clinical Trial

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

Study acronym: PRONATREOUS
Enrolling by Invitation
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Record status
This record was last updated May 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07576036
Lead Sponsor Rochester General Hospital
Collaborators: University of Pittsburgh Medical Center
Conditions Hyponatremia Symptomatic, Osmotic Demyelination Syndrome, Cerebral Edema
Enrollment 800 participants
Start Date 2023-11-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-08