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

March 4, 2026 updated by: Ezgi Günaydın

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult postoperative patients (aged 18 years and older) admitted to the intensive care unit. Patients are enrolled prospectively and followed using routinely collected clinical and laboratory data obtained at ICU admission and at 24 hours. Cardiac and thoracic surgery patients are excluded.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 28 days of ICU admission
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.
Within 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 28 days
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.
Within 28 days
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.
Within 28 days
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.
Within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ezgi Günaydın

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TrabzonMFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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