- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02545478
Biomarkers in Infection
Early Detection of Inflammatory Biomarkers in Infection
Visão geral do estudo
Status
Condições
Descrição detalhada
The body's immune system and a subsequent inflammatory response are triggered during infection. The detection of an activated immune system, and an indication of the degree of the host response, is helpful to the clinician both in assessing the severity of infection and in patient treatment and management. Currently, the white blood cell count and the differential are the most common laboratory parameters for measuring host response. The sedimentation rate and CRP are also used to detect inflammation. However, these tests are all imperfect predictors, and a test providing a better assessment of immune response would be helpful to the clinician in patient care. Additionally, understanding host response to infection may be helpful in understanding the biology and pathophysiology of sepsis. There are other biomarkers and inflammatory markers that may be found early in the initial presentation of infection such as cytokines (VEGF IL-1,IL-4,IL-6, IL-10, PAF, TNF, lectins iNoS,etc.) and clotting factors (protein C, d-dimer, complements involved in the clotting cascade, CRP, etc) that may provide a means of early detection of systemic inflammation, cell dysfunction, and related conditions. Early identification of patients at risk for systemic inflammatory syndromes, sepsis and septic shock may help direct patients to earlier antibiotic administration and early intervention with goal directed therapy. It may also serve as a tool for risk stratification when components such as age, comorbid illness and infection type are included.
The endothelium and endothelial cell markers are important in sepsis, yet a somewhat under-studied field of research. Additionally, the endothelium is a key regulator of the microcirculation, a place where oxygen diffusion occurs. One focus of this study is to measure endothelial markers (ie VEGF) and other cytokines with the goal of correlating these markers with severity of sepsis. Another focus is to study the response of various components in the blood, including the leukocytes, red cells, the endothelium, as well as cellular components such as the mitochondria. We will specifically look at alterations in thiamine, Vitamin D, CoQ10,l-carnitine and other nutrients as part of (and as related to) the body's response. Recently, a non-invasive method of assessing microvascular circulation by orthogonal polarization spectral (OPS) imagery has become available using a non-invasive technology known as orthogonal polarization spectroscopy. This technique enables direct visualization and quantification of microcirculatory blood flow, and represents an important surrogate outcome to which endothelial cell marker may be correlated. This will involve placing the microscopy probe gently against the sublingual mucosa and collecting a videotape of the circulation lasting about twenty seconds. This process involves minimal (or no) risk - it is akin to taking a temperature and uses no radiation. This videotape will be examined later by a novel software program that quantifies the circulation and used as an important surrogate outcome measure. Additionally, we are going to perform echocardiography to better understand the heart's response to sepsis, and correlated the molecular responses that we find with the changes in the responses by the heart.
This is a multicenter, observational pilot study which aims to evaluate how early biomarkers of infection an inflammation perform in identifying patients at risk for poor outcomes in sepsis and septic shock. The study will utilize a cohort of patients presenting to the ED with suspected infection as well as non-infected control population.
These patients will be compared with a non-infected population.
Enrolled subjects in the infected group will have blood samples and chart review obtained at enrollment, 24, 48 and 72 hours. For the control group, only a single blood draw will be collected at enrollment.
Enrolled subjects will also undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), extremity temperature as well as End-Tidal C02 measurements if a trained researcher is present.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Nathan Shapiro, MD MPH
- Número de telefone: 617-754-2343
- E-mail: nshapiro@bidmc.harvard.edu
Estude backup de contato
- Nome: Sharon R Hayes, RN
- Número de telefone: 617-754-2334
- E-mail: srhayes@bidmc.harvard.edu
Locais de estudo
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Aarhus, Dinamarca
- Ainda não está recrutando
- Aarhus Universitetshospital
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Contato:
- Hans Kirkegaard
- E-mail: Hans Kirkegaard <hanskirkegaard@dadlnet.dk>
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Investigador principal:
- Hans Kirkegaard, MD
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Recrutamento
- Beth Israel Deaconess Medical Center
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Contato:
- Nathan Shapiro, MD MPH
- Número de telefone: 617-754-2343
- E-mail: nshapiro@bidmc.harvard.edu
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Boston, Massachusetts, Estados Unidos, 02114
- Ativo, não recrutando
- Massachusetts General Hospital
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Boston, Massachusetts, Estados Unidos, 02215
- Ativo, não recrutando
- Brigham and Women's Hospital
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Worcester, Massachusetts, Estados Unidos, 01608
- Recrutamento
- St. Vincent's Hospital
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Contato:
- David Miru, RN
- Número de telefone: 508-363-5286
- E-mail: dmiru@bidmc.harvard.edu
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Contato:
- Pamel Sigel, RN
- Número de telefone: 508-363-7018
- E-mail: PAMELA.SIGEL@stvincenthospital.com
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Investigador principal:
- Nathan Shapiro, MD MPH
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New York
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Brooklyn, New York, Estados Unidos, 11215
- Recrutamento
- New York Methodist Hospital
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Contato:
- Robert Birkhahn, MD
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Investigador principal:
- Rorber Birkhahn, MD
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Recrutamento
- Vanderbiltt University
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Contato:
- Wesley Self, MD
- Número de telefone: 615-936-0253
- E-mail: wesley.self@vanderbilt.edu
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Investigador principal:
- Wesley Self, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria for Infected subjects:
- Age 18 years of age or older
- Confirmed or suspected infection
Inclusion Criteria for Control Subjects:
- Age 18 years of age or older
- A non-infectious clinical presentation to include
- Normal white blood cell count ( > 4,000 and/or < 12,000)
- Normothermia ( > 96.5 and/or less 100.4)
- Absence of the following clinical complaints: productive cough, fever, pyuria, rash
- No evidence of acute coronary syndrome
Exclusion Criteria for Control Subjects:
- Suspected infection
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Infected Group
subjects with suspected infection
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Non-infected group
subjects without any infection
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
28 day in-hospital mortality
Prazo: within 28 days after inclusion
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participants will be followed up for 28 days
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within 28 days after inclusion
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Organ Dysfunction assessed by Sepsis-related Organ Failure Assessment (SOFA) Score
Prazo: within 24 hours
|
within 24 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nathan Shapiro, MD MPH, Beth Israel Deaconess Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2005P000116
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