Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction (RASC-HypoNa)

November 4, 2024 updated by: ANACLARA MURUJOSA, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2037

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

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires

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

The study population consists of adult patients aged 18 years or older who were admitted to Hospital Italiano de Buenos Aires between 2010 and 2023 with severe hyponatremia, defined as a serum sodium (natremia) level of ≤ 120 mEq/L at the time of admission. The study focuses on patients experiencing their first hospitalization for this condition, with a hospital stay exceeding 24 hours to ensure sufficient follow-up for sodium correction. Patients with prior hospitalizations for severe hyponatremia or incomplete follow-up data were excluded to ensure accurate analysis of treatment outcomes.

Description

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.

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
Rapid group correction
Patients whose serum sodium increased by ≥ 8 mEq/L within the first 24 hours.
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.
Slow group correction
Patients whose serum sodium increased by < 8 mEq/L within the first 24 hours.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
From the date of hospital admission to the date of discharge
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).
From the date of hospital admission through hospital discharge, up to 180 days.

Collaborators and Investigators

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

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2024

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6756
  • 10042 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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