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Completed

NCT Number: NCT07380542

Dynamic Magnesium Replacement Strategies and 28-Day Mortality in Non-Cardiac Critically Ill Patients With Hypomagnesemia: A Target Trial Emulation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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