Biomarkers in Infection
Early Detection of Inflammatory Biomarkers in Infection
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Nathan Shapiro, MD MPH
- 電話番号:617-754-2343
- メール:nshapiro@bidmc.harvard.edu
研究連絡先のバックアップ
- 名前:Sharon R Hayes, RN
- 電話番号:617-754-2334
- メール:srhayes@bidmc.harvard.edu
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- 募集
- Beth Israel Deaconess Medical Center
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コンタクト:
- Nathan Shapiro, MD MPH
- 電話番号:617-754-2343
- メール:nshapiro@bidmc.harvard.edu
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Boston、Massachusetts、アメリカ、02114
- 積極的、募集していない
- Massachusetts General Hospital
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Boston、Massachusetts、アメリカ、02215
- 積極的、募集していない
- Brigham and Women's Hospital
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Worcester、Massachusetts、アメリカ、01608
- 募集
- St. Vincent's Hospital
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コンタクト:
- David Miru, RN
- 電話番号:508-363-5286
- メール:dmiru@bidmc.harvard.edu
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コンタクト:
- Pamel Sigel, RN
- 電話番号:508-363-7018
- メール:PAMELA.SIGEL@stvincenthospital.com
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主任研究者:
- Nathan Shapiro, MD MPH
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New York
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Brooklyn、New York、アメリカ、11215
- 募集
- New York Methodist Hospital
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コンタクト:
- Robert Birkhahn, MD
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主任研究者:
- Rorber Birkhahn, MD
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- 募集
- Vanderbiltt University
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コンタクト:
- Wesley Self, MD
- 電話番号:615-936-0253
- メール:wesley.self@vanderbilt.edu
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主任研究者:
- Wesley Self, MD
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Aarhus、デンマーク
- まだ募集していません
- Aarhus Universitetshospital
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コンタクト:
- Hans Kirkegaard
- メール:Hans Kirkegaard <hanskirkegaard@dadlnet.dk>
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主任研究者:
- Hans Kirkegaard, MD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Infected Group
subjects with suspected infection
|
Non-infected group
subjects without any infection
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
28 day in-hospital mortality
時間枠:within 28 days after inclusion
|
participants will be followed up for 28 days
|
within 28 days after inclusion
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Organ Dysfunction assessed by Sepsis-related Organ Failure Assessment (SOFA) Score
時間枠:within 24 hours
|
within 24 hours
|
協力者と研究者
捜査官
- 主任研究者:Nathan Shapiro, MD MPH、Beth Israel Deaconess Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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