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Идёт набор NCT07460141

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

Наблюдательное Postoperative Complications Critical Illness Inflammation Intensive Care Unit Admission

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Complications, Critical Illness, Inflammation, Intensive Care Unit Admission. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • In-hospital mortality (all-cause) [Срок оценки: Within 28 days of ICU admission]
  • Postoperative morbidity [Срок оценки: Within 28 days]
Вторичные конечные точки (4)
  • Antibiotic use [Срок оценки: Within 28 days]
  • Duration of mechanical ventilation [Срок оценки: Within 28 days]
  • ICU length of stay [Срок оценки: Within 28 days]
  • Infectious complications / sepsis [Срок оценки: Within 28 days]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Recep Erin — Trabzon

Идентификаторы

NCT: NCT07460141 · TrabzonMFA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗