HypomagnesemiaNCT07576621
Association Between Hypomagnesemia and Coagulopathy in Sepsis
An observational study of Hypomagnesemia and Coagulopathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to investigate the association between hypomagnesemia and coagulopathy in patients with sepsis, with a focus on evaluating whether low serum magnesium levels are independently linked to the development of disseminated intravascular coagulation during intensive care unit admission. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypomagnesemia, Coagulopathy, Sepsis
- What is being tested?
- Serum magnesium concentration
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a Prospective observational study included adult patients diagnosed with sepsis and conducted in the intensive care units of Ain Shams University Hospitals.
Who may be able to join
- Age ≥ 20 years at the time of Intensive Care Unit (ICU) admission.
- Diagnosis of sepsis based on Sepsis-3 criteria [confirmed or suspected infection + Sequential Organ Failure Assessment (SOFA) score ≥ 2].
- Admission to the ICU during the study period.
- Serum magnesium level measured at ICU admission.
- Coagulation parameters [e.g., platelet count, Prothrombin Time/International Normalized Ratio (PT-INR), fibrinogen, D-dimer] within 24 hours of ICU admission.
- Complete clinical and laboratory data for calculating the International Society on Thrombosis and Haemostasis (ISTH) overt Disseminated Intravascular Coagulation (DIC) score.
Who cannot join
- Patients with missing data on serum magnesium or coagulation markers at ICU admission.
- ICU admissions due to non-infectious causes (e.g., trauma, elective surgery without infection).
- Presence of pre-existing coagulopathy or hematologic malignancy affecting baseline coagulation (e.g., leukemia, hemophilia).
- Known history of magnesium supplementation prior to ICU admission.
- End-stage renal disease on dialysis, which may significantly alter magnesium handling.
- Pregnant women, due to altered magnesium physiology.
- Patients transferred from or to another hospital within 24 hours of ICU admission (incomplete follow-up).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association Between Hypomagnesemia and Coagulopathy in Sepsis
This study aimed to investigate the association between hypomagnesemia and coagulopathy in patients with sepsis, with a focus on evaluating whether low serum magnesium levels are independently linked to the development of disseminated intravascular coagulation during intensive care unit admission.
Read the detailed description
Sepsis is a life-threatening condition characterized by organ dysfunction resulting from a dysregulated host response to infection. It remains a major global cause of morbidity and mortality in intensive care units (ICUs).
Hypomagnesemia, commonly observed in ICU patients, has been associated with poor outcomes, including increased need for mechanical ventilation and extended ICU stays. Its immunomodulatory and vasoprotective functions make it a key factor in sepsis pathophysiology.
- Conditions
- Hypomagnesemia, Coagulopathy, Sepsis
- Being tested
- Serum magnesium concentration
- Medical subject headings
- Hemostatic Disorders, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum magnesium concentrationDiagnostic test
Serum magnesium concentration test was measured.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with hypomagnesemia. Receives: Diagnostic Test: Serum magnesium concentration | |
| Group II | Individuals with normal serum magnesium levels Receives: Diagnostic Test: Serum magnesium concentration | |
| Group III | Patients with hypermagnesemia. Receives: Diagnostic Test: Serum magnesium concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of disseminated intravascular coagulation
Incidence of disseminated intravascular coagulation (DIC) was recorded. International Society on Thrombosis and Haemostasis (ISTH) overt DIC score, a diagnostic system developed by the International Society on Thrombosis and Haemostasis. A score ≥ 5 will be used to define overt DIC, indicating systemic coagulation activation in the presence of a high-risk clinical condition
Measured: 5 days post-procedure
Secondary outcomes (3)
Incidence of Intensive Care Unit mortality
Incidence of Intensive Care Unit (ICU) mortality was recorded.
Measured: 5 days post-procedure
Length of Intensive Care Unit stay
Length of Intensive Care Unit stay was recorded.
Measured: 5 days post-procedure
Requirement for vasopressor therapy
Requirement for vasopressor therapy was recorded.
Measured: 5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Apr 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypomagnesemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed hamoda, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576621
- Sponsor's protocol ID
- FMASU MS 711/2025
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Hypomagnesemia and Coagulopathy in Sepsis
- ClinicalTrials.gov ID
- NCT07576621
- Acronym / sponsor ID
- FMASU MS 711/2025
- Conditions
- Hypomagnesemia, Coagulopathy, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 8 May 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 aimed to investigate the association between hypomagnesemia and coagulopathy in patients with sepsis, with a focus on evaluating whether low serum magnesium levels are independently linked to the development of disseminated intravascular coagulation during intensive care unit admission.
Detailed description
Sepsis is a life-threatening condition characterized by organ dysfunction resulting from a dysregulated host response to infection. It remains a major global cause of morbidity and mortality in intensive care units (ICUs).
Hypomagnesemia, commonly observed in ICU patients, has been associated with poor outcomes, including increased need for mechanical ventilation and extended ICU stays. Its immunomodulatory and vasoprotective functions make it a key factor in sepsis pathophysiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Serum magnesium concentrationPatients with hypomagnesemia. |
| Group II | – | Diagnostic Test: Serum magnesium concentrationIndividuals with normal serum magnesium levels |
| Group III | – | Diagnostic Test: Serum magnesium concentrationPatients with hypermagnesemia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a Prospective observational study included adult patients diagnosed with sepsis and conducted in the intensive care units of Ain Shams University Hospitals.
Key inclusion criteria (6 listed)
- Age ≥ 20 years at the time of Intensive Care Unit (ICU) admission.
- Diagnosis of sepsis based on Sepsis-3 criteria [confirmed or suspected infection + Sequential Organ Failure Assessment (SOFA) score ≥ 2].
- Admission to the ICU during the study period.
- Serum magnesium level measured at ICU admission.
- Coagulation parameters [e.g., platelet count, Prothrombin Time/International Normalized Ratio (PT-INR), fibrinogen, D-dimer] within 24 hours of ICU admission.
Key exclusion criteria (7 listed)
- Patients with missing data on serum magnesium or coagulation markers at ICU admission.
- ICU admissions due to non-infectious causes (e.g., trauma, elective surgery without infection).
- Presence of pre-existing coagulopathy or hematologic malignancy affecting baseline coagulation (e.g., leukemia, hemophilia).
- Known history of magnesium supplementation prior to ICU admission.
- End-stage renal disease on dialysis, which may significantly alter magnesium handling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum magnesium concentrationSerum magnesium concentration test was measured. | Diagnostic test | Group I, Group II, Group III |
Primary outcome
Incidence of disseminated intravascular coagulation
Time frame: 5 days post-procedure
Incidence of disseminated intravascular coagulation (DIC) was recorded. International Society on Thrombosis and Haemostasis (ISTH) overt DIC score, a diagnostic system developed by the International Society on Thrombosis and Haemostasis. A score ≥ 5 will be used to define overt DIC, indicating systemic coagulation activation in the presence of a high-risk clinical condition
3 secondary outcomes
Incidence of Intensive Care Unit mortality
Time frame: 5 days post-procedure
Length of Intensive Care Unit stay
Time frame: 5 days post-procedure
Requirement for vasopressor therapy
Time frame: 5 days post-procedure
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 8 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Hypomagnesemia
Active, not recruiting
Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
Ovarian Carcinoma
Not yet recruiting
Magnesium Supplementation as a Nutritional Intervention in Sarcopenia
Sarcopenia
RecruitingObservational study
The Study of Urinary Biomarkers in Patients With Hypomagnesemia
Hypomagnesemia
RecruitingPhase 4
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Hypomagnesemia
Not yet recruitingPhase 2
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Hypomagnesemia in Type 2 Diabetic Patients
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 and Coagulopathy, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 7 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 8 May 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 Egypt. 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?
Incidence of disseminated intravascular coagulation (time frame: 5 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.