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Идёт набор NCT06545838

Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome

— 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
В протоколе указаны: Analysis of plasma renin concentration.
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
Россия
Следующий шаг
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Официальное название

Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)

Обзор

The Surviving Sepsis Campaign (SSC) of 2021 characterizes sepsis as a life-threatening organ dysfunction caused by a dysregulated host response to infection, with a mortality rate of over 30%, which increases to 40% or more in the case of septic shock. Although concept of sepsis has improved, significant gaps remain in assessing its clinical severity and predicting patient outcomes. Recognized markers of the severity of septic shock are procalcitonin (PCT), presepsin, and, to a certain extent, lactate. Elevated lactate levels result from a shift to anaerobic glycolysis and indicate inadequate oxygen delivery to tissues. Despite the importance of procalcitonin in the course of sepsis, it has proven to be a suboptimal diagnostic biomarker for the development of sepsis, with sensitivity and specificity below 80%. As a result, the use of procalcitonin in addition to clinical assessment to determine the indications for initiating antibiotic therapy is not recommended. Meanwhile, presepsin, although a potential biomarker for the early diagnosis of sepsis, also has only moderate accuracy according to current data and cannot be used as the only test for the diagnosis of sepsis. Renin is a crucial enzyme in the renin-angiotensin-aldosterone system (RAAS), which plays an important role in the regulation of blood pressure, tissue perfusion, and the balance of water and electrolytes. Thus, renin may be the sensitive biomarker with good prognostic qualities in the context of sepsis and septic shock. Preliminary studies have indicated that elevated renin levels may act as an indicator of patient severity, and could also be used as a marker for the development of septic shock and mortality prognosis. This study aims to address these gaps by investigating the role of renin as a biomarker for the severity of sepsis and septic shock, focusing on its potential for more accurate prediction of clinical outcomes.

Вмешательства

  • Другое Analysis of plasma renin concentration
    The concentration of plasma renin in patients will be assessed using the immunochemiluminescent method

Первичные конечные точки

  • Correlation between blood renin concentration and norepinephrine dosage [Срок оценки: Through study completion, an average of 2 years]
Вторичные конечные точки (7)
  • Correlation between blood renin concentration and blood procalcitonin concentration [Срок оценки: Through study completion, an average of 2 years]
  • Correlation between blood renin concentration and peripheral blood flow [Срок оценки: Through study completion, an average of 2 years]
  • Correlation between blood renin concentration and SOFA score [Срок оценки: Through study completion, an average of 2 years]
  • Correlation between blood renin concentration and renal replacement therapy free days [Срок оценки: Through study completion, an average of 2 years]
  • 28-days mortality [Срок оценки: 28 days]
  • Frequency of Major Adverse Kidney Events (MAKE) [Срок оценки: 28 days]
  • Correlation between blood renin concentration and blood lactate concentration [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Hospitalization in the intensive care unit
  • Confirmed diagnosis of Sepsis within 24 hours
  • Signed informed consent or a decision by the medical council to include the patient in the study

Критерии исключения

  • Any surgical intervention on the kidneys and/or adrenal glands performed within 28 days prior to the patient's inclusion in the study
  • Patients previously included in this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Россия · 1 центр
  • Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology — Moscow

Идентификаторы

NCT: NCT06545838 · SOS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗