Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction

NCT06675591 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2037

Last updated 2024-11-05

No results posted yet for this study

Summary

This study examines the impact of different rates of sodium correction on the outcomes of patients with severe hyponatremia (serum sodium ≤ 120 mEq/L). Hyponatremia is a condition where blood sodium levels are dangerously low, and its treatment must be carefully managed to avoid complications. Standard guidelines recommend correcting sodium levels slowly to prevent a rare but serious neurological condition called osmotic demyelination syndrome (ODS). However, recent evidence suggests that a faster rate of sodium correction may reduce hospital stay length and mortality without increasing the risk of ODS.

This retrospective study, conducted from 2010 to 2023 at a hospital in Buenos Aires, Argentina. It compares the outcomes of patients who had their sodium levels corrected rapidly (≥ 8 mEq/L in 24 hours) to those who had slower corrections. The primary outcomes measured are mortality and the development of ODS.

Conditions

  • Hyponatremia
  • Hospitalisation
  • Mortality
  • SEVERE HYPONATREMIA

Interventions

OTHER

Rapid sodium correction

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization: Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours. Slow Sodium Correction: An increase in serum sodium of \< 8 mEq/L within 24 hours. The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

OTHER

Slow sodium correction

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization: Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours. Slow Sodium Correction: An increase in serum sodium of \< 8 mEq/L within 24 hours. The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER
  • Hospital Privado de Comunidad de Mar del Plata

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • Hospital Italiano de Buenos Aires

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-04-30
Completion
2024-05-01

Countries

  • Argentina

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06675591 on ClinicalTrials.gov