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NCT Number: NCT07460141

IL-6 and Hemogram-Derived Inflammatory Indices for Mortality Prediction in Postoperative ICU Patients

This prospective observational cohort study aims to evaluate the predictive value of interleukin-6 (IL-6) levels and hemogram-derived inflammatory scores for morbidity and in-hospital mortality in postoperative patients admitted to the intensive care unit (ICU). IL-6 levels and inflammatory indices will be assessed at ICU admission and at 24 hours using data obtained from routine clinical care. Associations between these biomarkers and clinical outcomes, including mortality, morbidity, antibiotic use, and duration of mechanical ventilation, will be evaluated after adjustment for illness severity.

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Key information

Conditions

Postoperative Complications Critical Illness Disease Attributes Inflammation Intensive Care Unit Admission Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This prospective observational cohort study will include adult postoperative patients admitted to the intensive care unit (ICU). The study is purely observational, and no additional interventions or procedures will be performed beyond routine clinical care.

Interleukin-6 (IL-6) levels will be recorded at ICU admission (0 hour) and at 24 hours. Routine laboratory parameters obtained during standard clinical follow-up, including complete blood count, C-reactive protein (CRP), and albumin levels, will be used to calculate hemogram-derived inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), neutrophil-to-monocyte ratio (NMR), CRP-to-albumin ratio (CAR), CRP-to-lymphocyte ratio (CLR), and the modified systemic inflammation score (mSIS).

Illness severity and comorbidity burden will be assessed using established scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), and the Charlson Comorbidity Index. Demographic characteristics, surgical variables (type and duration of surgery), and clinical outcomes will be prospectively recorded.

The primary objective is to evaluate the predictive value of IL-6 levels and inflammatory indices for in-hospital mortality. Secondary objectives include associations with postoperative morbidity, infectious complications, antibiotic use, duration of mechanical ventilation, organ dysfunction, and ICU length of stay. Changes in IL-6 levels and inflammatory indices between ICU admission and 24 hours will also be explored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Postoperative patients admitted to the ICU
  • Availability of complete clinical and laboratory data at ICU admission and at 24 hours
  • Provision of informed consent by the patient or legally authorized representative

Exclusion criteria

  • Age < 18 years
  • Thoracic surgery patients
  • Cardiac surgery patients

Treatment and study plan

Primary outcomes

  1. In-hospital mortality (all-cause)

    Time frame: Within 28 days of ICU admission

    In-hospital all-cause mortality within 28 days of intensive care unit admission, assessed using routinely collected clinical data.

  2. Postoperative morbidity

    Time frame: Within 28 days

    Postoperative morbidity within 28 days of intensive care unit admission. Postoperative morbidity includes sepsis defined according to Sepsis-3 criteria and acute kidney injury defined according to KDIGO criteria, assessed using routinely collected clinical data.

Secondary outcomes

  1. Antibiotic use

    Time frame: Within 28 days

    Use of systemic antibiotic therapy during the hospital stay, assessed within 28 days of intensive care unit admission using routinely recorded clinical data.

  2. Duration of mechanical ventilation

    Time frame: Within 28 days

    Duration of invasive mechanical ventilation, measured as total number of days of ventilatory support within 28 days following intensive care unit admission.

  3. ICU length of stay

    Time frame: Within 28 days

    Length of stay in the intensive care unit, defined as the number of days from ICU admission to ICU discharge.

  4. Infectious complications / sepsis

    Time frame: Within 28 days

    Development of infectious complications, including sepsis defined according to Sepsis-3 criteria, during the hospital stay within 28 days of ICU admission.

Study contacts

Contact information is provided by the study sponsor or research team.

Ezgi Günaydın, MD

CONTACT

[email protected]

+905336834198

Sponsors and collaborators

Lead sponsor

Ezgi Günaydın

Other

Registry information

Official study title

The Effects of IL-6 and Inflammation Scores on Mortality in Postoperative Patients Admitted to the Intensive Care Unit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 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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