- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Gyeonggi-do
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Seongnam, Gyeonggi-do, Korean tasavalta, 463-707
- Seoul National University Bundang Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Postive culture rates of blood and bile juice
Aikaikkuna: 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.
|
1 week after culture test
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Identification of bacterial species in blood and bile cultures
Aikaikkuna: 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 bacterial species in each samples and compate those each other.
|
1 week after culture test
|
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Identification of antibiotics sensitive and resistant bacterial species
Aikaikkuna: 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.
|
1 week after culture test
|
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Identification of colonized bacterial species
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojen puheenjohtaja: Jaihwan Kim, M.D., Seoul National University Bundang Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SNUBH-IMGPB-2014-01
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