- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02545478
Biomarkers in Infection
Early Detection of Inflammatory Biomarkers in Infection
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Nathan Shapiro, MD MPH
- 전화번호: 617-754-2343
- 이메일: nshapiro@bidmc.harvard.edu
연구 연락처 백업
- 이름: Sharon R Hayes, RN
- 전화번호: 617-754-2334
- 이메일: srhayes@bidmc.harvard.edu
연구 장소
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Aarhus, 덴마크
- 아직 모집하지 않음
- Aarhus Universitetshospital
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연락하다:
- Hans Kirkegaard
- 이메일: Hans Kirkegaard <hanskirkegaard@dadlnet.dk>
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수석 연구원:
- Hans Kirkegaard, MD
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- 모병
- Beth Israel Deaconess Medical Center
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연락하다:
- Nathan Shapiro, MD MPH
- 전화번호: 617-754-2343
- 이메일: nshapiro@bidmc.harvard.edu
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Boston, Massachusetts, 미국, 02114
- 모집하지 않고 적극적으로
- Massachusetts General Hospital
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Boston, Massachusetts, 미국, 02215
- 모집하지 않고 적극적으로
- Brigham and Women's Hospital
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Worcester, Massachusetts, 미국, 01608
- 모병
- St. Vincent's Hospital
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연락하다:
- David Miru, RN
- 전화번호: 508-363-5286
- 이메일: dmiru@bidmc.harvard.edu
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연락하다:
- Pamel Sigel, RN
- 전화번호: 508-363-7018
- 이메일: PAMELA.SIGEL@stvincenthospital.com
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수석 연구원:
- Nathan Shapiro, MD MPH
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New York
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Brooklyn, New York, 미국, 11215
- 모병
- New York Methodist Hospital
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연락하다:
- Robert Birkhahn, MD
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수석 연구원:
- Rorber Birkhahn, MD
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Tennessee
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Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbiltt University
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연락하다:
- Wesley Self, MD
- 전화번호: 615-936-0253
- 이메일: wesley.self@vanderbilt.edu
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수석 연구원:
- Wesley Self, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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28 day in-hospital mortality
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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Organ Dysfunction assessed by Sepsis-related Organ Failure Assessment (SOFA) Score
기간: within 24 hours
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within 24 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nathan Shapiro, MD MPH, Beth Israel Deaconess Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .