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Идёт набор NCT07582926

Cortisol Levels and Mortality in Septic Shock ICU Patients

— Наблюдательное Sepsis Septic Shock

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: Sepsis, Septic Shock. 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
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Официальное название

Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study

Обзор

This prospective observational study aims to evaluate the prognostic value of cortisol levels and their dynamic changes in critically ill patients with sepsis and septic shock admitted to the intensive care unit. Cortisol plays a crucial role in maintaining hemodynamic stability and modulating the inflammatory response during critical illness, and relative adrenal insufficiency has been associated with worse clinical outcomes. Adult patients admitted to the intensive care unit with sepsis or septic shock will be enrolled and followed prospectively. Serum cortisol levels will be measured, and their association with clinical outcomes, including intensive care unit mortality, 28-day mortality, and 90-day mortality, will be analyzed. In addition, the relationship between cortisol levels and disease severity scores such as SOFA and APACHE, as well as laboratory parameters including inflammatory biomarkers, will be evaluated. The findings of this study are expected to contribute to the early identification of high-risk patients and improve prognostic assessment in critically ill patients with sepsis and septic shock.

Первичные конечные точки

  • 1.ICU mortality [Срок оценки: During the first 28 days of ICU stay; if the patient is discharged from the ICU to the ward or dies earlier, the follow-up period will end at that time.]
  • 28 day mortality [Срок оценки: Up to 28 days after ICU admission]
  • 90 day mortality [Срок оценки: Up to 90 days after ICU admission]
Вторичные конечные точки (6)
  • Length of ICU stay [Срок оценки: The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.]
  • Mechanical Ventilation Requirement [Срок оценки: The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.]
  • Vasopressor Requirement [Срок оценки: The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.]
  • Sequential Organ Failure Assessment (SOFA) score [Срок оценки: The occurrence of septic shock during ICU stay will be evaluated. Although the timing may vary for each patient, septic shock is expected to occur within the first 28 days for most patients. If the duration extends beyond 28 days, follow-up will continue]
  • APACHE II score [Срок оценки: The occurrence of septic shock during ICU stay will be evaluated. Although the timing may vary for each patient, septic shock is expected to occur within the first 28 days for most patients. If the duration extends beyond 28 days, follow-up will continue]
  • Association between cortisol levels and laboratory parameters [Срок оценки: The occurrence of septic shock during ICU stay will be evaluated. Although the timing may vary for each patient, septic shock is expected to occur within the first 28 days for most patients. If the duration extends beyond 28 days, follow-up will continue]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Admission to the intensive care unit for more than 24 hours
  • Presence of a clinically or microbiologically confirmed source of infection
  • Diagnosis of sepsis or septic shock during ICU stay

Критерии исключения

  • Pregnancy
  • Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis
  • Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)

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
  • Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07582926 · AEŞH-BADEK1-2025-412

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗