The Effects of IL-6 and Inflammation Scores on Mortality in Postoperative Patients Admitted to the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- In-hospital mortality (all-cause)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years
- •Thoracic surgery patients
- •Cardiac surgery patients
结局指标
主要结局
In-hospital mortality (all-cause)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Ezgi Günaydın
research assistant
Trabzon Kanuni Education and Research Hospital