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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypertonic 3% saline.
- Who it may be relevant to
- Registry conditions: Hyponatremia Symptomatic, Osmotic Demyelination Syndrome, Cerebral Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurological Complications Associated With Serum Sodium ≤110 mmol/L and Its Treatment: An International Multi-Centre Retrospective Study.
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
Interventions
- Drug Hypertonic 3% saline
Rapid Correction of hyponatremia
Primary outcome measures
- Osmotic demyelination syndrome [Time frame: 1 to 14 days]
- MRI-confirmed Osmotic Demyelination Syndrome [Time frame: Within 30 days]
Secondary outcome measures (1)
- Cerebral edema [Time frame: 2 days]
Eligibility criteria
Inclusion criteria
- Serum sodium ≤110 mmol/L at admission to the hospital
Exclusion criteria
- Blood glucose >15 mmol/L, spurious laboratory dataa
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Pittsburgh School of Medicine — Pittsburgh
Identifiers
NCT: NCT07576036 · 3042A PRONATREOUS