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Набор по приглашению NCT06808100

Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock

— Наблюдательное Sepsis Septic Shock Multi Organ Failure

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, Multi Organ Failure. 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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Обзор

The aim of this observational study is to investigate whether GDF-15 levels can predict clinical outcome in patients admitted to the intensive care unit with a diagnosis of septic shock. The main question is: * Can the level of GDF-15 levels during ICU admission predict the development of multiple organ failure in patients with septic shock? All patients will continue to receive routine treatment for sepsis and septic shock. The investigators will observe the development of multiple organ failure by the Sequential Organ Failure Assessment (SOFA) score increase

Подробное описание

Sepsis can be defined as a disproportionate host response to infection. It has been reported that 2.8 million deaths per year in high-income countries are associated with sepsis. Excessive inflammatory response may lead to organ failure and death after multiple organ failure. After infection, pathogen-mediated molecular fragments (PAMPS) are formed and recognised by toll-like receptors and the immune system is activated. Pro- and anti-inflammatory mediators are released and levels of various cytokines increase. These changes affect neutrophil-endothelial adhesion, disrupt the coagulation cascade and increase microthrombi formation. The systemic inflammatory state may be followed by immune paralysis and secondary infections, which may lead to the loss of patients as a result of multiple organ failure.

Growth differentiation factor-15 (GDF-15), also known as macrophage inhibitory cytokine-1 (MIC-1), is a member of the transforming growth factor-β (TGFβ) superfamily. It is found in many tissues and is strongly expressed in epithelial cells and macrophages. Its level is correlated with macrophage activation. In recent years, circulating GDF-15 level has been identified as a biomarker with prognostic value in cardiopulmonary diseases such as heart failure myocardial infarction and pulmonary embolism. In addition, elevated GDF-15 levels have been shown in end-stage renal failure and acute respiratory distress syndrome and chronic inflammatory diseases.

Septic shock requires vasopressor support to maintain a mean arterial pressure of 65 mmHg despite adequate fluid replacement. Septic shock has a higher mortality rate and development of multiple organ failure is more common.

Although the correlation of elevated GDF-15 levels with organ failure has been shown, the relationship between GDF-15 levels and multiple organ failure in patients with septic shock has not yet been studied.

Primary aim in this study is to investigate the relationship between GDF-15 level measured after admission and progression to multiple organ failure in patients admitted to intensive care with septic shock.

Secondary aim is to predict mortality with GDF-15 level in patients treated in intensive care unit with septic shock.

Первичные конечные точки

  • Predicting the progression to multiple organ failure in patients admitted to intensive care unit with septic shock by GDF-15 level [Срок оценки: Time from intensive care unit admission to mortality at the 28th day.]
Вторичные конечные точки (1)
  • 28-day intensive care mortality [Срок оценки: 28 days after intensive care unit admission]

Критерии участия

Критерии включения

  • Patients older thab 18 years of age
  • Patients with septic shock
  • Patients without end-stage renal failure (KDIGO G4,G5)
  • Patients without chronic liver disease
  • Patients with New York Heart Association (NYHA) stage 1-2
  • Patients not diagnosed with active cancer
  • Non-pregnant patients
  • Patients without chronic immunodeficiency
  • Patients without chronic inflammatory disease

Критерии исключения

  • Patients younger than 18 years age
  • Patients not diagnosed with septic shock
  • Patients with end-stage renal failure
  • Patients with chronic liver disease
  • Patients with New York Heart Association (NYHA) stage 3-4
  • Patients diagnosed with active cancer
  • Pregnant patients
  • Patients with chronic immunodeficiency
  • Patients with chronic inflammatory diseases

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 Bilkent City Hospital — Ankara

Идентификаторы

NCT: NCT06808100 · TABED 2-24-659

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗