- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00908635
The Role of Angiopoietin, Tie-2, and Vascular Endothelial Growth Factor (VEGF) in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)
The Role of Angiopoietin, Angiopoietin Receptor Tie-2, and Vascular Endothelial Growth Factor in Sepsis-Induced Multi-Organ Dysfunction Syndrome
연구 개요
상태
상세 설명
Multiple Organ Dysfunction Syndrome (MODS) frequently leads to death in patients with sepsis. Our previous work has demonstrated that endothelial injury is closely associated with MODS development and mortality in septic patients. The sepsis-induced damage of endothelial cell membrane gives rise to increased capillary permeability. Evidence suggests that increased capillary permeability in patients with sepsis was associated with higher incidence of MODS and death during the ICU stay than those with decreased permeability. Angiopoietin (Ang) system is the key mediator for maintaining capillary permeability. Ang-2 triggers an inflammatory response and inducing permeability by activating the endothelium. In contrast, Ang-1 is anti-inflammatory, can inhibit adhesion molecule expression and attenuate permeability increase in different stimuli. The disrupted angiopoietin system has been reported in patients with sepsis, but the association between angiotension and MODS in septic patients has not been well addressed.
This study is designated to determine serum concentrations of Ang-1, Ang-2, Ang-1/Ang-2 ratio, and Tie-2 in patients with sepsis-induced MODS and to investigate the association among increased permeability, inflammatory mediators,autonomic dysfunction, and these serum mediators in development of organ failure. In addition, the study will incubate endothelial cells with septic patients' serum or tumor necrosis factor (TNF)-alfa, and determine the effects of ang-1 administration and blockade of ang-2 on disruption of endothelial cell structure, permeability increase, and expression of adhesion molecules. The study will also determine the signaling pathways and altered NF-kB dimmer composition that is responsible for the inhibitory effect for ang-1 administration on TNF-alfa-induced intercellular adhesion molecule (ICAM)-1 expression on endothelial surface.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Taoyuan, 대만, 333
- 모병
- Chang Gung memorial hospital
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연락하다:
- Shu-Min Lin, MD
- 전화번호: 8467 88633281200
- 이메일: smlin100@gmail.com
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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:
Patients must have known origin of infection plus at least 2 of the following criteria of systemic inflammatory response syndrome:
- fever > 38C or hypothermia < 36C;
- heart rate > 90 beats/ minute;
- respiratory rate > 20 breaths/minute or PaCO2< 32 mmHg or mechanical ventilation for an acute process;
- WBC count > 12x109/L or < 4x109/L or > 10% immature neutrophils.
Exclusion Criteria:
- Age less than 18 years,
- Pregnant,
- Inability to provide informed, written consent,
- Patients with urologic trauma resulting in frank hematuria, urinary infection, or existing chronic renal disease (serum creatinine level > 2.0 mg/dL),
- Patients receiving nephrotoxic drugs, admitted to the hospital following a surgical procedure, or remaining in the ICU for < 72 hours will be also excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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survivor
survivors of patients
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fatalities
non-survivors of patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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mortality
기간: in hospital mortality
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in hospital mortality
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2차 결과 측정
결과 측정 |
기간 |
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organ failure
기간: In ICU stay
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In ICU stay
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shu-Min Lin, MD, Chang Gung memorial hospital
간행물 및 유용한 링크
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 (추정)
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. .