Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction

Completed

• Conditions: Hyponatremia; Hospitalisation; Mortality; SEVERE HYPONATREMIA

• Registration Number: NCT06675591
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-05-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-14
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2037

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-Hospital Mortality	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 Outcome Measures

Name	Time	Method
30-Day Mortality	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.
Length of stay	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.
Incidence of Osmotic Demyelinitation Syndrome (ODS)	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).

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina