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CompletedNCT07380542Updated Feb 2, 2026

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

An observational study in Hypomagnesemia, sponsored by Fujian Provincial Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Fujian Provincial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12,887
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hypomagnesemia

Keywords

  • Magnesium Replacement Therapy
  • 28-Day Mortality
  • Intensive Care Unit Patients
  • Target Trial Emulation
  • Retrospective Cohort Study
03

In context

Lead sponsor

Fujian Provincial Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study includes adult (≥18 years) non-cardiac critically ill patients with hypomagnesemia (serum magnesium \< 1.7 mg/dL) within 72 hours of ICU admission, identified from the MIMIC-IV (version 3.1) database (2008-2019). Patients with cardiac-related admission or missing key data are excluded. The population represents a diverse cohort of non-cardiac ICU patients (e.g., respiratory, gastrointestinal, neurological etiologies) to evaluate the association between dynamic magnesium replacement strategies and 28-day mortality.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Admitted due to cardiac or cardiosurgical causes (e.g., Cardiac Surgery Recovery Unit, CCU, CVICU).
  2. Underwent cardiac surgery during hospitalization (identified by ICD-9/10 procedure codes).
  3. Primary discharge diagnosis of major cardiac conditions (e.g., myocardial infarction, heart failure, arrhythmias).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12,887 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 28-Day All-Cause Mortality

    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)

    Time frame: 28 days after t0

07

Study locations

1 site
  • Fujian Provincial Hospital
    Fuzhou, Fujian 350001, China
08

References and documents

Publications

  • Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18. PubMed 26994063 ↗
  • Johnson AEW, Bulgarelli L, Shen L, Gayles A, Shammout A, Horng S, Pollard TJ, Hao S, Moody B, Gow B, Lehman LH, Celi LA, Mark RG. MIMIC-IV, a freely accessible electronic health record dataset. Sci Data. 2023 Jan 3;10(1):1. doi: 10.1038/s41597-022-01899-x. PubMed 36596836 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 24, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data (IPD) cannot be shared because the study uses data from the MIMIC-IV database, which requires researchers to complete mandatory training and obtain independent authorization from the MIMIC-IV Data Access Committee. IPD is not owned by the study team; qualified researchers may access the data directly via the official MIMIC-IV application process (https://mimic.mit.edu/).

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07380542
Lead sponsor
Fujian Provincial Hospital
Responsible party
Han Chen (Professor, Fujian Provincial Hospital) — Principal investigator
First posted
Feb 2, 2026
Start date
Sep 1, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Feb 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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