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临床试验/NCT06675591
NCT06675591已完成不适用

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

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 2,037 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,037
试验地点
1
主要终点
In-Hospital Mortality

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

In-Hospital Mortality

时间窗: 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.

次要结局

  • 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.)
  • Length of stay(From the date of hospital admission to the date of discharge)
  • Incidence of Osmotic Demyelinitation Syndrome (ODS)(From the date of hospital admission through hospital discharge, up to 180 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ANACLARA MURUJOSA

Principal Investigator

Hospital Italiano de Buenos Aires

研究点 (1)

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