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Идёт набор NCT07425587

Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study

— 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 22 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary objective of this study is to establish an IL-6 concentration cutoff that predicts sepsis or septic shock (according to the Third International Consensus Definitions (Sepsis-3 criteria)) in patients who are admitted or are intended to be admitted to the hospital from the emergency department with suspected infection.

Первичные конечные точки

  • Sepsis (according to the Third International Consensus Definitions (Sepsis-3 criteria)) within 3 days after inclusion. [Срок оценки: Within 3 days after inclusion]
Вторичные конечные точки (12)
  • In-hospital mortality up to 30 days [Срок оценки: Within 30 days after inclusion]
  • In-hospital mortality up to 7 days [Срок оценки: Within 7 days after inclusion]
  • Sequential Organ Failure Assessment (SOFA) score [Срок оценки: Within 3 days after inclusion]
  • Hospital Length of Stay [Срок оценки: Participants will be followed up for hospital length of stay for up to 30 days]
  • ICU length of stay [Срок оценки: Within 30 days after inclusion]
  • Bacterial vs viral infection (As assessed by cultures and/or viral testing) [Срок оценки: Within 30 days after inclusion]
  • Progression to septic shock [Срок оценки: Within 30 days after inclusion]
  • 30-day all-cause mortality in patients with a final diagnosis of sepsis or septic shock [Срок оценки: Within 30 days after inclusion]
  • Initiation of vasopressor therapy (by hospital discharge or up to 30 days) [Срок оценки: within 30 days after inclusion]
  • Initiation of renal replacement therapy (by hospital discharge or up to 30 days) [Срок оценки: Within 30 days after inclusion]
  • Initiation of mechanical ventilation (by hospital discharge or up to 30 days) [Срок оценки: Within 30 days after inclusion]
  • Free days from vasopressor therapy (by hospital discharge or up to 30 days) [Срок оценки: Within 30 days after inclusion]

Критерии участия

Критерии включения

  • Adult patients (≥22 years of age)
  • Intent to admit to hospital or admitted to the hospital via the emergency department
  • At least 0.6 mL plasma drawn (optimal 1 mL) and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of (i.e., up to 12 hours after) presentation to the emergency department. For Cohort 1, Criterion #1 criteria should be met within 3 hours of sample collection (fresh or remnant).
  • Meets criteria for at least one of the 3 cohorts (patients may be included in more than one cohort) within 12 hours of emergency department presentation:

1\. Cohort 1 (Systemic inflammatory response or culture ordered):

  • Criterion #1 (2 of below within 3 hours of sample collection, of which 1 is at least (A) or (B))
  • A) body temperature >38C or <36C,
  • B) HR>90 beats/min,
  • C) respiratory rate >20 breaths/min, or
  • D) white blood cell count > 12K or <4K/microliters or over 10% immature forms or bands) OR:
  • Criterion #2 (order for culture of a body fluid (e.g., blood, urine, sputum))

2\. Cohort 2 (Treatment for suspected infection initiated):

  • Meets criteria for Cohort 1 and antimicrobials (antibiotics or antivirals) ordered.

3\. Cohort 3 (Confirmed or strong evidence of infection):

  • Meets criteria for Cohorts 1 and 2, AND 1 or more of the following criteria:
  • Temp >101F (38.3C)
  • pneumonia by x-ray or CT,
  • Urinalysis with WBC>10/HPF;
  • Intraabdominal-pelvis infection by CT, U/S, or MRI
  • Skin / soft tissue infection by clinical exam
  • Evidence of meningitis on LP;
  • Positive microbiological culture (cultures drawn within 3 days of presentation)
  • Suspected line infection (e.g. redness or pus around the line)

Критерии исключения

  • Prisoners or imprisonment at time of enrollment
  • Pregnant
  • Prior enrollment into this study
  • Informed consent as approved by IRB is unable to be obtained.
  • Environmental exposure (e.g., heat exposure)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 5 центров
  • University of Florida College of Medicine — Gainesville
  • Beth Israel Deaconess Medical Center — Boston
  • Wake Forest School of Medicine — Winston-Salem
  • Vanderbilt University Medical Center — Nashville
  • Intermountain Health — Salt Lake City

Идентификаторы

NCT: NCT07425587 · CES-0009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗