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NCT Number: NCT06675591

Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction

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.

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Key information

Conditions

Hyponatremia Hospitalisation Metabolic Diseases Mortality Nutritional and Metabolic Diseases SEVERE HYPONATREMIA Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older.
  • First hospitalization at Hospital Italiano de Buenos Aires with a serum sodium (natremia) level ≤ 120 mEq/L at admission.

Exclusion criteria

  • Absence of serum sodium values after the first 24 hours of hospitalization.
  • Hospitalizations shorter than 24 hours.
  • Patients with previous hospitalizations prior to the study period where admission serum sodium levels were ≤ 120 mEq/L.

Treatment and study plan

Rapid sodium correction

Other

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.

Slow sodium correction

Other

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.

Primary outcomes

  1. In-Hospital Mortality

    Time frame: From hospital admission to discharge or death. To evalute in-Hospital mortality we will use logistic regression, not time to event analysis.

    In-Hospital Mortality refers to the occurrence of death from any cause during a patients hospital stay. In the context of this study, it specifically measures the rate at which patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) die before being discharged from the hospital.

Secondary outcomes

  1. 30-Day Mortality

    Time frame: From the date of hospital admission up to 30 days. From hospital admission to discharge or death. To evalute 30-Day mortality we will use logistic regression, not time to event analysis.

    30-Day Mortality refers to the occurrence of death from any cause within 30 days following a patient's admission to the hospital. In this study, it measures the mortality rate of patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) within 30 days after hospitalization, regardless of whether they were discharged or remained in the hospital.

  2. Length of stay

    Time frame: From the date of hospital admission to the date of discharge

    Length of Stay (LOS) refers to the duration of a patient's hospitalization, measured from the date of admission to the date of discharge. In this study, it evaluates how long patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) remain in the hospital and assesses whether the rate of sodium correction (rapid vs. slow) influences their hospital stay.

  3. Incidence of Osmotic Demyelinitation Syndrome (ODS)

    Time frame: From the date of hospital admission through hospital discharge, up to 180 days.

    Incidence of Osmotic Demyelination Syndrome (ODS) refers to the number of new cases of ODS that occur in patients during or after the correction of severe hyponatremia (serum sodium ≤ 120 mEq/L).

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Collaborators

  • Hospital Privado de Comunidad de Mar del Plata
  • University of California, Irvine
  • University of Pittsburgh

Registry information

Official study title

Mortality and Neurologic Complications Associated With Rapid Versus Slow Correction of Hyponatremia

Acronym: RASC-HypoNa

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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