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Completed

NCT Number: NCT06887439

Association of EASIX in Sepsis

This prospective study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis.

The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis
  • All patients over the age of 18

Exclusion criteria

  • • Patients under the age of 18
  • Patients with a history of multiple intensive care admissions
  • Patients who died within 24 hours of diagnosis
  • Patients diagnosed with CRF or currently treated for ARF
  • Patients with deficient serum creatinine, LDH and platelet values at the time of diagnosis Patients for whom consent could not be obtained from themselves or their relatives

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: 28 days

    The primary finding of the study was 28-day mortality after sepsis diagnosis

Secondary outcomes

  1. Septic shock

    Time frame: 28 days

    Septic shock was defined according to the SEPSIS-3 guidelines as the need for vasopressors or inotropes in patients diagnosed with sepsis.

  2. Acute kidney injury

    Time frame: 28 days

    Acute kidney injury was defined according to KDIGO guidelines as a ≥0.3 mg/dL increase in serum creatinine over 48 hours, a ≥1.5-fold increase in serum creatinine over 7 days, or urine output <0.5 mL/kg/hour for 6 consecutive hours.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Association of Endothelial Activation and Stress Index With Mortality and Poor Prognosis in Sepsis: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Jan 21, 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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