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

Conditions

• Cerebral Edema
• Hyponatremia Symptomatic
• Osmotic Demyelination Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hypertonic 3% saline — DRUG
  Rapid Correction of hyponatremia

Study Details

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

Key Dates

Start date

Nov 1, 2023

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

800 participants (estimated)

Arms

• Arm: Patients with suspected or MRI-confirmed ODS
  Patients without suspected or MRI-confirmed ODS

Primary Outcome Measure

Osmotic demyelination syndrome [ Time Frame: 1 to 14 days ]

Locations (1)

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