Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care

NCT07430787 | Active Not Recruiting

• 1 other identifier: T194/2022-1
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objectives and Hypothesis To determine the incidence of hyponatremia at TYKS and the factors associated with it. To assess how rapidly hyponatremia was corrected and how the rate of correction affected patient prognosis. To evaluate treatment modalities and their impact on patient prognosis, length of hospital stay, and their appropriateness in comparison with national and international treatment guidelines. To determine the incidence of osmotic demyelination at TYKS and the factors associated with it. To assess other complications and their clinical significance. To evaluate the impact of hyponatremia on various endpoints, such as mortality, length of hospital stay, seizures, confusion, and similar outcomes.

Conditions

Hyponatremia; Osmotic Demyelination Syndrome; Alcohol Use Disorder

Keywords

hyponatremia; epidemiology; Osmotic Demyelination Syndrome; Alchol use disorder

Outcome Measures

Primary Outcomes (2)

• Prevalence of ODS in hyponatremia patients

  The primary variable is dichotomous. It is defined based on radiologists' reports and confirmed by an expert panel.

  From enrollment to the end of the treamtent period. Usually 2-21 days.

• Osmotic demyelination syndrome

  Dichotomic 0/1, outcome defined from radiology reports.

  During the study period 1.1.2010-31.12.2020 wiht recorded sodium values.

Secondary Outcomes (2)

• Epidemiology and correction rates of hyponatremia

  During any 24-hour period during the treatment period.

• Prognosis linked to severe or moderate hyponatremia

  1, 6 and 12 months after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study design was to enroll as general population that are hospitalized as possible. From this population the main focus group of hyponatremia and ODS patients were selected and formed case-control groups.

You may qualify if:

• Two sodium measurements in Tyks laboratories between 12-36 hours.

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

University of Turku

Turku, Southwest Finland, 20300, Finland

Location

Related Publications (5)

• Kalampokini S, Artemiadis A, Zis P, Hadjihannas L, Parpas G, Kyrri A, Hadjigeorgiou GM. Osmotic demyelination syndrome improving after immune-modulating treatment: Case report and literature review. Clin Neurol Neurosurg. 2021 Sep;208:106811. doi: 10.1016/j.clineuro.2021.106811. Epub 2021 Jul 24.

  PMID: 34358802 BACKGROUND

• Baek SH, Jo YH, Ahn S, Medina-Liabres K, Oh YK, Lee JB, Kim S. Risk of Overcorrection in Rapid Intermittent Bolus vs Slow Continuous Infusion Therapies of Hypertonic Saline for Patients With Symptomatic Hyponatremia: The SALSA Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):81-92. doi: 10.1001/jamainternmed.2020.5519.

  PMID: 33104189 BACKGROUND

• Verbalis JG, Goldsmith SR, Greenberg A, Schrier RW, Sterns RH. Hyponatremia treatment guidelines 2007: expert panel recommendations. Am J Med. 2007 Nov;120(11 Suppl 1):S1-21. doi: 10.1016/j.amjmed.2007.09.001.

  PMID: 17981159 BACKGROUND

• Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns RH, Thompson CJ. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med. 2013 Oct;126(10 Suppl 1):S1-42. doi: 10.1016/j.amjmed.2013.07.006.

  PMID: 24074529 BACKGROUND

• Lambeck J, Hieber M, Dressing A, Niesen WD. Central Pontine Myelinosis and Osmotic Demyelination Syndrome. Dtsch Arztebl Int. 2019 Sep 2;116(35-36):600-606. doi: 10.3238/arztebl.2019.0600.

  PMID: 31587708 BACKGROUND

MeSH Terms

Conditions

Hyponatremia; Alcoholism

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: September 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)