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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 28 days after t0 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26994063 | Background | 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. | |
| 36596836 | Background | 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. |
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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/).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 24, 2025 | Jan 24, 2026 | Prot_SAP_000.pdf |
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