Postoperative ComplicationsNCT07460141
IL-6 and Hemogram-Derived Inflammatory Indices for Mortality Prediction in Postoperative ICU Patients
An observational study of Postoperative Complications and Critical Illness, run by Ezgi Günaydın at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Critical Illness, Inflammation
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Mar 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Thoracic surgery patients
- Cardiac surgery patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Erin
Trabzon
Ezgi Günaydın, MD, +905336834198, ezgunaydin@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Complications, Critical Illness, Inflammation, Intensive Care Unit Admission
- Keywords
- Interleukin-6, IL-6, Inflammatory indices, Postoperative, Intensive care, Mortality, Biomarkers
- Medical subject headings
- Postoperative Complications, Critical Illness, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality (all-cause)
In-hospital all-cause mortality within 28 days of intensive care unit admission, assessed using routinely collected clinical data.
Measured: Within 28 days of ICU admission
Postoperative morbidity
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.
Measured: Within 28 days
Secondary outcomes (4)
Antibiotic use
Use of systemic antibiotic therapy during the hospital stay, assessed within 28 days of intensive care unit admission using routinely recorded clinical data.
Measured: Within 28 days
Duration of mechanical ventilation
Duration of invasive mechanical ventilation, measured as total number of days of ventilatory support within 28 days following intensive care unit admission.
Measured: Within 28 days
ICU length of stay
Length of stay in the intensive care unit, defined as the number of days from ICU admission to ICU discharge.
Measured: Within 28 days
Infectious complications / sepsis
Development of infectious complications, including sepsis defined according to Sepsis-3 criteria, during the hospital stay within 28 days of ICU admission.
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Dec 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ezgi Günaydın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ezgi Günaydın, Trabzon Kanuni Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460141
- Sponsor's protocol ID
- TrabzonMFA
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of IL-6 and Inflammation Scores on Mortality in Postoperative Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07460141
- Acronym / sponsor ID
- TrabzonMFA
- Conditions
- Postoperative Complications, Critical Illness, Inflammation, Intensive Care Unit Admission
- Keywords
- Interleukin-6, IL-6, Inflammatory indices, Postoperative, Intensive care, Mortality, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ezgi GünaydınUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Thoracic surgery patients
- Cardiac surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
Antibiotic use
Time frame: Within 28 days
Duration of mechanical ventilation
Time frame: Within 28 days
ICU length of stay
Time frame: Within 28 days
Infectious complications / sepsis
Time frame: Within 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Critical Illness, run by Ezgi Günaydın at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ezgi Günaydın, MD (+905336834198, ezgunaydin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (all-cause) (time frame: Within 28 days of ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.