CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,037 enrolled
Drug / intervention
Rapid sodium correction +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06675591
NCT06675591N/ACompleted

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

Hospital Italiano de Buenos Aires·observational·Posted Nov 5, 2024·Updated Nov 5, 2024

In Brief

An observational study evaluating Rapid sodium correction and Slow sodium correction for Hyponatremia and 3 related conditions. Completed, enrolled 2,037 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesArgentina

Timeline

N/ACompletedFinished
20252026
First PostedNov 5, 2024
Enrollment StartMar 1, 2024
Primary CompletionApr 30, 2024
Study CompletionMay 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 1.7 years ago

Interventions

Rapid sodium correctionother

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 correctionother

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.