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

N/AEnrolling By InvitationNCT07576036

Rochester General Hospital800 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

800

Conditions

Hyponatremia Symptomatic Osmotic Demyelination Syndrome Cerebral Edema

Interventions

Hypertonic 3% salineDRUG

Rapid Correction of hyponatremia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Serum sodium ≤110 mmol/L at admission to the hospital Exclusion Criteria: * Blood glucose \>15 mmol/L, spurious laboratory dataa

Locations (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Cerebral edema

Cerebral edema documented by imaging or death or respiratory arrest from suspected cerebral edema

Time frame: 2 days

Data from ClinicalTrials.gov

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