An observational study in Hyponatremia Symptomatic, Osmotic Demyelination Syndrome and Cerebral Edema, sponsored by Rochester General Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Rochester General Hospital · Observational
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
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's planned enrollment of 800 is above the median of 88 across 31 observational studies indexed under Brain Edema.
Browse Brain Edema studies →Rochester General Hospital is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients age 18 or higher with serum sodium ≤110 mmol/L
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients without suspected or MRI-confirmed ODS
Drug: Hypertonic 3% saline
Rapid Correction of hyponatremia
Also known as: Desmopressin, 5% dextrose in water
Osmotic demyelination syndrome
Neurological deterioration after treatment of hyponatremia
Time frame: 1 to 14 days
MRI-confirmed Osmotic Demyelination Syndrome
Post treatment neurological deterioration with CPM and/or EPM
Time frame: Within 30 days
Cerebral edema
Cerebral edema documented by imaging or death or respiratory arrest from suspected cerebral edema
Time frame: 2 days
Plan to share: Yes — Serum sodium values, outcomes and correction rates
Supporting information: Study protocol, Statistical analysis plan
Time frame: June 30 2026 to June 30 2034
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Sep 2026, 34 months after the start.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Rochester General Hospital