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 (PRONATREOUS)

May 4, 2026 updated by: Rochester General Hospital

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected or MRI-confirmed ODS
Patients without suspected or MRI-confirmed ODS
Drug: Hypertonic 3% saline
Rapid Correction of hyponatremia
Other Names:
  • Desmopressin
  • 5% dextrose in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osmotic demyelination syndrome
Time Frame: 1 to 14 days
Neurological deterioration after treatment of hyponatremia
1 to 14 days
MRI-confirmed Osmotic Demyelination Syndrome
Time Frame: Within 30 days
Post treatment neurological deterioration with CPM and/or EPM
Within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral edema
Time Frame: 2 days
Cerebral edema documented by imaging or death or respiratory arrest from suspected cerebral edema
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Collaborators

University of Pittsburgh Medical Center

Investigators

  • Study Chair: Richard H Sterns, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3042A PRONATREOUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Serum sodium values, outcomes and correction rates

IPD Sharing Time Frame

June 30 2026 to June 30 2034

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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