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临床试验/NCT07380542
NCT07380542已完成不适用

Dynamic Magnesium Replacement Strategies and 28-Day All-Cause Mortality in Non-Cardiac Critically Ill Patients With Hypomagnesemia: A Target Trial Emulation Using the MIMIC-IV Database (2008-2019)

Fujian Provincial Hospital1 个研究点 分布在 1 个国家目标入组 12,887 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
12,887
试验地点
1
主要终点
28-Day All-Cause Mortality

研究概览

简要总结

This study looks at how different ways of giving magnesium (a nutrient) affect the risk of death within 28 days for adults with low magnesium levels who are in the intensive care unit (ICU) for non-heart-related reasons. We will use data from past ICU patients (2008-2019) to compare three approaches:

No magnesium treatment (even if levels are low); Daily magnesium treatment (regardless of daily levels); Dynamic treatment (only giving magnesium when daily tests show low levels). The goal is to find out which strategy is safest and most effective for this group of patients.

详细描述

This is a target trial emulation (a type of observational study that mimics a clinical trial) using data from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database (2008-2019).

Inclusion criteria: Adults (≥18 years) admitted to the ICU, with serum magnesium <1.7 mg/dL within 72 hours of admission, and no history of heart disease or cardiac surgery.

Sample size: 12,887 patients. Interventions (simulated): Three magnesium replacement strategies (Never Treat, Always Treat, Dynamic Treat).

Outcome: 28-day all-cause mortality (death from any cause). Analysis methods: We will use the G-formula (to handle time-varying factors that could affect results) and sensitivity analyses to check if findings are reliable.

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

  • Age ≥ 18 years.
  • Admitted to the Intensive Care Unit (ICU).
  • Developed hypomagnesemia (Serum Magnesium < 1.7 mg/dL) within the first 72 hours of ICU admission.

排除标准

  • Admitted due to cardiac or cardiosurgical causes (e.g., Cardiac Surgery Recovery Unit, CCU, CVICU).
  • Underwent cardiac surgery during hospitalization (identified by ICD-9/10 procedure codes).
  • Primary discharge diagnosis of major cardiac conditions (e.g., myocardial infarction, heart failure, arrhythmias).

研究组 & 干预措施

Never Treat Group

Patients with hypomagnesemia who received no magnesium replacement therapy during their ICU stay, regardless of daily serum magnesium levels

Always Treat Group

Patients with hypomagnesemia who received daily magnesium replacement therapy during their ICU stay, regardless of daily serum magnesium levels

Dynamic Treat Group

Patients with hypomagnesemia who received magnesium replacement therapy only on days when their daily serum magnesium level was <1.7 mg/dL during their ICU stay

结局指标

主要结局

28-Day All-Cause Mortality

时间窗: 28 days after t0

Death from any cause within 28 days after t0 (t0 = the first time serum magnesium \<1.7 mg/dL is detected within 72 hours of hospital admission)

次要结局

未报告次要终点

研究者

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

Han Chen

Professor

Fujian Provincial Hospital

研究点 (1)

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