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Идёт набор NCT05875740

Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study

— Наблюдательное Sepsis Inflammatory Response

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, Inflammatory Response. Базовые параметры: 18 лет — 60 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis. Single-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice. This observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.

Первичные конечные точки

  • Absolute number of CD8+T subsets in the peripheral blood (0 hour) [Срок оценки: 0 hour after study inclusion]
  • Absolute number of CD8+T subsets in the peripheral blood (24 hours) [Срок оценки: 24 hours after study inclusion]
  • Absolute number of CD8+T subsets in the peripheral blood (48 hours) [Срок оценки: 48 hours after study inclusion]
  • Absolute number of CD8+T subsets in the peripheral blood (72 hours) [Срок оценки: 72 hours after study inclusion]
  • proliferation of CD8+T subsets in the peripheral blood (0 hour) [Срок оценки: 0 hour after study inclusion]
  • proliferation of CD8+T subsets in the peripheral blood (24 hours) [Срок оценки: 24 hours after study inclusion]
  • proliferation of CD8+T subsets in the peripheral blood (48 hours) [Срок оценки: 48 hours after study inclusion]
  • proliferation of CD8+T subsets in the peripheral blood (72 hours) [Срок оценки: 72 hours after study inclusion]
  • ICU length of stay [Срок оценки: up to 4 weeks]
  • PD-1 expression of CD8+T subsets in the peripheral blood (24 hours) [Срок оценки: 24 hours after study inclusion]
Вторичные конечные точки (12)
  • Mechanical ventilation time after inclusion [Срок оценки: up to 4 weeks]
  • Total hospital length of stay [Срок оценки: up to 4 weeks]
  • In-hospital mortality [Срок оценки: up to 4 weeks]
  • 90-day readmission rate [Срок оценки: up to 4 weeks]
  • Infection complications [Срок оценки: up to 4 weeks]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Срок оценки: 0h after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Срок оценки: 24 hours after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Срок оценки: 48 hours after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Срок оценки: 72 hours after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Срок оценки: 0 hour after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Срок оценки: 24 hours after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Срок оценки: 48 hours after study inclusion]

Критерии участия

Критерии включения

Patients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; No sedative drugs with elimination half-life were used before inclusion in the study; Patients and/or their family members know and agree to participate in the trial.

Критерии исключения

History of solid organ or bone marrow transplantation; Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma; Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc); Pregnancy or lactation; Chronic nephrosis; Severe chronic liver disease (child-Pugh: Grade C); alcohol or opioid dependence, mental illness, or severe cognitive impairment; Patients and/or their family members refuse to participate in the trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong Uni — Ухань

Идентификаторы

NCT: NCT05875740 · ZJC202304

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗