HypomagnesemiaNCT07380542
Dynamic Magnesium Replacement Strategies and 28-Day Mortality in Non-Cardiac Critically Ill Patients With Hypomagnesemia: A Target Trial Emulation
An observational study of Hypomagnesemia, run by Fujian Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypomagnesemia
- How many people
- 12,887 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Conditions
- Hypomagnesemia
- Keywords
- Magnesium Replacement Therapy, 28-Day Mortality, Intensive Care Unit Patients, Target Trial Emulation, Retrospective Cohort Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days after t0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Chen, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380542
- Sponsor's protocol ID
- HChen-MgReple2025
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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/).
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 26994063Johnson 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 at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07380542
- Acronym / sponsor ID
- HChen-MgReple2025
- Conditions
- Hypomagnesemia
- Keywords
- Magnesium Replacement Therapy, 28-Day Mortality, Intensive Care Unit Patients, Target Trial Emulation, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,887 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 26994063Hernan 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.
- Background: PubMed 36596836Johnson 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.
- Individual participant dataSharing planned: 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypomagnesemia, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day All-Cause Mortality (time frame: 28 days after t0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380542, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.