- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02107560
Results of Bile and Blood Culture in Patients With Acute Cholangitis
A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity
Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no obstruction, however, it can be infected with bacteria when there is a stasis or obstruction. After infection, cholangitis can be developed because of systematic endotoxemia or bacteremia. Though identification of bacteria is very important for selection of adequate antibiotics, treatment with empirical antibiotics is commonly performed when identification of bacteria is not possible.
Identification of bacteria is usually done with blood or bile culture. In the previous studies, the same results from blood and bile were common in patients with cholangitis. However, the data of these studies were based on the bile juice which was aspirated by surgery. Considering that bile duct obstruction is usually treated with endoscopy or radiological intervention without surgery, it is necessary to collect data with endoscopic or radiologic intervention. In addition, the concordant rate of these two tests has not been reported according to severity of cholangitis. As a result, the necessities of bile and blood culture are not agreed among experts in this fields.
Our hypothesis is that concordant rates of bile and blood culture are same in patients with each moderate or severe cholangitis. However, the concordant rates of bile and blood culture are different between patients with moderate and severe cholangitis. This study will assess the positive rates of blood and bile culture in patients with moderate or severe cholangitis, respectively and compare the results according to the different severity.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Gyeonggi-do
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Seongnam, Gyeonggi-do, 대한민국, 463-707
- Seoul National University Bundang Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with moderate or severe cholangitis which fullfilled the criteria by the Tokyo Guidelines (Tanaka A, Takada T, Kawarada Y, et al. Antimicrobial therapy for acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:59-67.)
- Patients who are successfully treated with endoscopic or radiologic biliary drainage
- Patients who undergo both blood and bile culture tests
Exclusion Criteria:
- Patients with other infections except cholangitis or cholecystitis
- Patients who received surgical biliary drainage treatment
- Patients who are treated with endoscopic or radiologic biliary drainage more than 24 hours after using initial antibiotics
- Patients who does not agree with informed consent or who are vulnerable subjects
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Postive culture rates of blood and bile juice
기간: 1 week after culture test
|
Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital.
After the completion of study, we will analyze the positive culture rates in each samples and compate those each other.
In addition, we will compare the results according to the severity of cholangitis.
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1 week after culture test
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Identification of bacterial species in blood and bile cultures
기간: 1 week after culture test
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Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital.
After the completion of study, we will analyze the bacterial species in each samples and compate those each other.
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1 week after culture test
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Identification of antibiotics sensitive and resistant bacterial species
기간: 1 week after culture test
|
Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital.
After the completion of study, we will analyze the antibiotics sensitive and resistant bacterial species in each samples and compate those each other.
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1 week after culture test
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Identification of colonized bacterial species
기간: 1 week after culture test
|
Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital.
After the completion of study, we will analyze the colonized bacterial species which is not true pathogens in each samples and compate those each other.
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1 week after culture test
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공동 작업자 및 조사자
수사관
- 연구 의자: Jaihwan Kim, M.D., Seoul National University Bundang Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .