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

NCT07576036 | Enrolling By Invitation

• 1 other identifier: 3042A PRONATREOUS
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyponatremia Symptomatic; Osmotic Demyelination Syndrome; Cerebral Edema

Keywords

Treatment and outcome of severe hyponatremia

Outcome Measures

Primary Outcomes (2)

• Osmotic demyelination syndrome

  Neurological deterioration after treatment of hyponatremia

  1 to 14 days

• MRI-confirmed Osmotic Demyelination Syndrome

  Post treatment neurological deterioration with CPM and/or EPM

  Within 30 days

Secondary Outcomes (1)

• Cerebral edema

  2 days

Study Arms (1)

Patients with suspected or MRI-confirmed ODS

Patients without suspected or MRI-confirmed ODS

Drug: Hypertonic 3% saline

Interventions

Hypertonic 3% saline DRUG

Rapid Correction of hyponatremia

Also known as: Desmopressin, 5% dextrose in water

Patients with suspected or MRI-confirmed ODS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 18 or higher with serum sodium ≤110 mmol/L

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rochester General Hospital: lead
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Brain Edema

Interventions

Sodium Chloride; Deamino Arginine Vasopressin; Glucose; Water

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Richard H Sterns, MD

  University of Rochester

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: June 30 2026 to June 30 2034

Locations

US (1)