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Completed

NCT Number: NCT07576621

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Serum magnesium concentration

Diagnostic Test

Serum magnesium concentration test was measured.

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of Intensive Care Unit mortality

    Time frame: 5 days post-procedure

    Incidence of Intensive Care Unit (ICU) mortality was recorded.

  2. Length of Intensive Care Unit stay

    Time frame: 5 days post-procedure

    Length of Intensive Care Unit stay was recorded.

  3. Requirement for vasopressor therapy

    Time frame: 5 days post-procedure

    Requirement for vasopressor therapy was recorded.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of the Association Between Hypomagnesemia and Coagulopathy in Sepsis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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