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Association Between Hypomagnesemia and Coagulopathy in Sepsis

Evaluation of the Association Between Hypomagnesemia and Coagulopathy in Sepsis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07576621
Enrollment
150
Registered
2026-05-08
Start date
2025-04-01
Completion date
2025-04-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy, Hypomagnesemia, Sepsis

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTSerum magnesium concentration

Serum magnesium concentration test was measured.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Incidence of disseminated intravascular coagulation5 days post-procedureIncidence 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

Secondary

MeasureTime frameDescription
Incidence of Intensive Care Unit mortality5 days post-procedureIncidence of Intensive Care Unit (ICU) mortality was recorded.
Length of Intensive Care Unit stay5 days post-procedureLength of Intensive Care Unit stay was recorded.
Requirement for vasopressor therapy5 days post-procedureRequirement for vasopressor therapy was recorded.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026