Current partner codePEPTIDESDE
NCT07576036·Not applicable·OBSERVATIONAL

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

Status

Enrolling by invitation

Phase

Not applicable

Enrollment

800

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Hypertonic 3% saline

Rapid Correction of hyponatremia

Timeline

From registration to results.

  1. First posted

    May 8, 2026

  2. Study start

    Nov 1, 2023

  3. Primary completion

    Jun 30, 2026

  4. Study completion

    Jun 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    May 8, 2026

Outcomes

What the study measures.

Primary outcomes

Osmotic demyelination syndrome

Time frame · 1 to 14 days

Neurological deterioration after treatment of hyponatremia

MRI-confirmed Osmotic Demyelination Syndrome

Time frame · Within 30 days

Post treatment neurological deterioration with CPM and/or EPM

Secondary outcomes

Cerebral edema

Time frame · 2 days

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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