NCT07460141

Brief 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). 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

Interleukin-6IL-6Inflammatory indicesPostoperativeIntensive careMortalityBiomarkers

Outcome Measures

Primary Outcomes (2)

  • In-hospital mortality (all-cause)

    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

    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 Outcomes (4)

  • Antibiotic use

    Within 28 days

  • Duration of mechanical ventilation

    Within 28 days

  • ICU length of stay

    Within 28 days

  • Infectious complications / sepsis

    Within 28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Erin

Trabzon, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsCritical IllnessInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

Ezgi Günaydın, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

December 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations