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Enrolling by Invitation

NCT Number: NCT07576036

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

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

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Key information

Conditions

Hyponatremia Symptomatic Brain Diseases Brain Edema Central Nervous System Diseases Cerebral Edema Nervous System Diseases Osmotic Demyelination Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Serum sodium ≤110 mmol/L at admission to the hospital

Exclusion criteria

  • Blood glucose >15 mmol/L, spurious laboratory dataa

Treatment and study plan

Hypertonic 3% saline

Drug

Rapid Correction of hyponatremia

Other names: Desmopressin, 5% dextrose in water

Primary outcomes

  1. Osmotic demyelination syndrome

    Time frame: 1 to 14 days

    Neurological deterioration after treatment of hyponatremia

  2. MRI-confirmed Osmotic Demyelination Syndrome

    Time frame: Within 30 days

    Post treatment neurological deterioration with CPM and/or EPM

Secondary outcomes

  1. Cerebral edema

    Time frame: 2 days

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

Sponsors and collaborators

Lead sponsor

Rochester General Hospital

Other

Collaborators

  • University of Pittsburgh Medical Center

Registry information

Official study title

Neurological Complications Associated With Serum Sodium ≤110 mmol/L and Its Treatment: An International Multi-Centre Retrospective Study.

Acronym: PRONATREOUS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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