Association Between Hypomagnesemia and Coagulopathy in Sepsis

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Coagulopathy; Hypomagnesemia
• Intervention / Treatment: Diagnostic test: Serum magnesium concentration

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Patients with hypomagnesemia.	Diagnostic test: Serum magnesium concentration; Serum magnesium concentration test was measured.
Group II; Individuals with normal serum magnesium levels	Diagnostic test: Serum magnesium concentration; Serum magnesium concentration test was measured.
Group III; Patients with hypermagnesemia.	Diagnostic test: Serum magnesium concentration; Serum magnesium concentration test was measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Intensive Care Unit mortality	Incidence of Intensive Care Unit (ICU) mortality was recorded.	5 days post-procedure
Length of Intensive Care Unit stay	Length of Intensive Care Unit stay was recorded.	5 days post-procedure
Requirement for vasopressor therapy	Requirement for vasopressor therapy was recorded.	5 days post-procedure

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Sepsis; Hemostatic Disorders
• Other Study ID Numbers: FMASU MS 711/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No