Association Between Hypomagnesemia and Coagulopathy in Sepsis

NCT07576621 | Completed

• 1 other identifier: FMASU MS 711/2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypomagnesemia; Coagulopathy; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Intensive Care Unit mortality

  5 days post-procedure

• Length of Intensive Care Unit stay

  5 days post-procedure

• Requirement for vasopressor therapy

  5 days post-procedure

Study Arms (3)

Group I

Patients with hypomagnesemia.

Diagnostic Test: Serum magnesium concentration

Group II

Individuals with normal serum magnesium levels

Diagnostic Test: Serum magnesium concentration

Group III

Patients with hypermagnesemia.

Diagnostic Test: Serum magnesium concentration

Interventions

Serum magnesium concentration DIAGNOSTIC_TEST

Serum magnesium concentration test was measured.

Group I; Group II; Group III

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Hemostatic Disorders; Sepsis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Intensive Care, Anaesthesia and Pain Management, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)