- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01957254
Investigate the Activity of Endotoxin in Severe Sepsis
Investigate the Activity of Endotoxin in Patients With Severe Sepsis and Septic Shock
연구 개요
상세 설명
Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock.
The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients.
The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test. Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin. The critical component of the LAL reagents used in endotoxin tests is derived from blood cells (amebocytes) of the horseshoe crab, Limulus polyphemus. It contains the proteins of the blood clotting mechanism, which is triggered by endotoxins. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter 85) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (Part I, General Tests, No. 6). We will adopt the chromogenic method as purchased from the Associates of Cape Cod Inc. (ACC). The LAL reagent is formulated with a synthetic substrate which gives a yellow color when acted upon by endotoxin activated enzyme. The test is read at 405 nm, usually in a microplate reader. The severity of multiple organ dysfunction and 28-day mortality will be followed up.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Taipei, 대만
- National Taiwan University Hospital
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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:
- ICU patients with new onset of severe sepsis and septic shock
- Presence of at least 2 of the following conditions (These criteria should have occurred between 12 hours before or 6 hours after the onset of the qualifying first organ dysfunction)
- Fever or hypothermia (body temperature over 38 ℃ or under 36 ℃
- Tachycardia (heart rate > 90 bpm)
- Tachypnea (respiratory rate over 20 breaths/min or under mechanical ventilation)
- Leukocyte count more than 12,000 cells/mm3, less than 4,000 cells/mm3, or more than 10 % of immature form (band)
Exclusion Criteria:
Patient will be excluded if they
- are under 20 years old or older than 99 years old
- have suffered from severe sepsis or septic shock more than 24 hours
- are pregnant
- were treated with another medicine or device in the trial less than 30 days prior to the admission to this trial
- have received organ transplantation less than 1 years prior to this trial
- are terminally ill, for examples with metastasis, with a life expectancy of less than 30 days (certified by the attending physician)
- have already received other blood cleaning treatments, such as CVVH, HD, HF, and PE upon entry into the trial
- have chosen palliative care and signed Do Not Resuscitate sheet
- non-native speaker
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Severe Sepsis
Patient with severe sepsis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Endotoxin activity
기간: baseline
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The endotoxin activity will be measured by Limulus Amebocyte Lysate (LAL) test.
Limulus Amebocyte Lysate (LAL) test will be used to detect and quantify serum level of endotoxin.
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baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of endotoxin activity
기간: At enrollment, 24h, 48h, and 72h
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Compare the change of endotoxin activity at different time points.
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At enrollment, 24h, 48h, and 72h
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yu-Chang Yeh, Ph.D., Department of Anesthesiology, National Taiwan University Hospital
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
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