Набор скоро начнётся NCT07735741

Immune Dysregulation During Sepsis: A Natural History Cohort

— Наблюдательное Sepsis Septic Shock Sepsis-Associated Immune Dysregulation

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, Sepsis-Associated Immune Dysregulation. Базовые параметры: 18 лет — 100 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

Background: Sepsis is an illness that occurs when the body s immune system runs out of control. This can damage organs. Sepsis causes an estimated 1 in 5 deaths worldwide. In this natural history study, researchers want to learn more about how the immune system changes during sepsis. They hope this knowledge will help them find better ways to treat sepsis. Objective: To understand how sepsis affects the body over time. Eligibility People aged 18 years and older admitted to INOVA Fairfax Hospital in Virginia and who have sepsis. Design: Researchers will collect data from participants medical records. Participants will have blood drawn at least 5 times while they are in the hospital. Blood may be collected for up to 30 days, if they remain in the hospital that long. The blood will be taken from access lines that are already in place. Some blood draws will be optional. Participants may opt to have up to 3 tests of their heart function while they are in the hospital. Some participants may have a sample of fluid collected from their lungs. Participants will have a follow-up visit about 90 days after they join the study. This visit will be by phone call if they have left the hospital. They will fill out a questionnaire. They will answer questions about their health and how they feel. The call will last about 30 minutes....

Подробное описание

Study Description:

This is a natural history study intended to allow the characterization of neutrophil biology and other contributors to the pathogenesis along with short-term outcomes of patients hospitalized with sepsis. Patients admitted to INOVA Fairfax Hospital with sepsis will be enrolled, undergo clinical evaluation, clinical data capture, and will have blood drawn that will be processed and analyzed at the NIH.

Objectives:

The aim of this natural history/observational study is to develop a cohort of patients admitted to the hospital with sepsis who can be followed longitudinally to achieve the following:

Primary objectives:

To investigate the contribution of neutrophils and neutrophil subsets including low density neutrophils to the dysregulated immune response that occurs during the acute phase of sepsis.

Secondary objective:

-To characterize spleen tyrosine kinase expression across immune cells and correlate with soluble biomarkers, cellular phenotypes and gene expression to determine mechanistic pathways that may be amenable to host-direct therapies.

Exploratory:

-To identify novel cellular and soluble phenotypes using multiomic and functional datasets and correlate them with clinical sepsis phenotypes, mortality, and cardiac dysfunction to inform sepsis clinical trajectory and novel therapeutic targets.

Endpoints:

Primary Endpoint:

Changes in the frequency, activation and functional status of neutrophils and neutrophil subsets including low density neutrophils during the acute phase of sepsis and their association with in hospital mortality.

Secondary Endpoints:

-Changes in spleen tyrosine kinase expression across immune cells and its correlation with soluble biomarkers, cellular phenotypes and gene expression and their association with in hospital mortality.

Exploratory:

-Identification of novel cellular and soluble immunological signatures of immune dysregulation during sepsis and their association with cardiac dysfunction, disease severity, and in hospital mortality.

Первичные конечные точки

To investigate the contribution of neutrophils and neutrophil subsets including low density neutrophils to the dysregulated immune response that occurs during the acute phase of sepsis. [Срок оценки: 10 years]

Вторичные конечные точки (1)

To characterize spleen tyrosine kinase expression across immune cells and correlate with soluble biomarkers, cellular phenotypes and gene expression to determine mechanistic pathways that may be amenable to host-direct therapies. [Срок оценки: 10 years]

Критерии участия

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Age >= 18 years old
Admitted to INOVA Fairfax Hospital
Meets sepsis-3 definition of sepsis in the last 48 hours

Suspected infection
Evidence of organ dysfunction (SOFA score >= 2)
Ability of subject or LAR to understand and the willingness to sign a written informed consent document

Критерии исключения

Any individual who meets any of the following criteria will be excluded from participation in this study:

Hemoglobin < 7 microgram/dL at the time of enrollment
Hemoglobin <10 microgram/dL in patients with known coronary artery disease or active EKG changes consistent with acute ischemia
Currently receiving infusion of epinephrine; or dopamine at an infusion rate of > 2.5

microgram/kg/min, norepinephrine of > 20 mircogram/min, or vasopressin > 0.04 units/min