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The Necessity of Bile Cultures in Patients With Acute Cholangitis

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ClinicalTrials.gov Identifier: NCT02601417
Recruitment Status : Unknown
Verified September 2017 by Sang Hyub Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 10, 2015
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE November 10, 2015
Last Update Posted Date September 8, 2017
Actual Study Start Date  ICMJE August 27, 2015
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2015)
Organ Failure [ Time Frame: 48 hours ]
  1. Shock
    • Systolic blood pressure under 90mmHg after adequate volume resuscitation
    • Vassopressors or inotropics needed to maintain effective circulation
  2. Acute kidney injury (KDIGO 2012)
    • Increase in SCr by >= 0.3mg/dl within 48 hours
    • Increase in SCr to >= 1.5 times baseline, known or presumed within 7 days
    • Urine volume < 0.5mg/kg/h for 6 hours
  3. Altered mentality
    • Glasgow coma scale (GCS) < 12
    • or GCS score decrease > 3
  4. Acute respiratory distress
    • Pulse oxygen saturation < 90%
    • Mechanical ventilation applied
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02601417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2015)
  • Hospital days [ Time Frame: Expected average of 7 days ]
  • Re-intervention for biliary drainage [ Time Frame: Expected average of 2 days ]
  • Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Necessity of Bile Cultures in Patients With Acute Cholangitis
Official Title  ICMJE The Necessity of Bile Cultures in Patients With Acute Cholangitis
Brief Summary Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo guideline, but the clinical significance is yet unproven. And its results might indicate less information of the true pathogen regarding normal flora. Previous study conducted at our institute found drug-resistant pathogens identified in bile culture had no impact on the outcome. So the investigators are conducting a multicenter randomized controlled trial comparing groups which considers both blood and bile culture as control and which considers only blood culture as trial group in order to prove bile culture provides no additional helpful clinical information.
Detailed Description This study includes patients who are diagnosed acute cholangitis and had percutaneous transhepatic biliary drainage (PTBD) as the modality of biliary drainage. All patients will start empirical antibiotics as soon as they are diagnosed acute cholangitis. Randomization will be done after the blood sample and bile sample for culture are obtained. The patients will be allocated to one of the control or trial group. Patients in control group considers both blood and bile culture for the choice of antibiotics, and patients in trial group considers only blood culture for the choice of antibiotics. Organ failure and mortality rate are the primary outcomes. Data will be analyzed as intention-to-treat (ITT) and per-protocol (PP). The rate of organ failure and mortality will be analyzed by Pearson chi-square & Fisher exact test.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute Cholangitis
Intervention  ICMJE Other: Ignoring result of bile culture
Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.
Study Arms  ICMJE
  • No Intervention: Control
    Group which considers both blood culture and bile culture for antibiotics choice
  • Experimental: Trial
    Group which considers only blood culture and ignore bile culture for antibiotics choice. Patients in this arm would undergo bile culture but ignore the result when choosing antibiotics
    Intervention: Other: Ignoring result of bile culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2015)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed acute cholangitis (as 2013 Tokyo guideline)
  • Percutaneous transhepatic biliary drainage

Exclusion Criteria:

  • Pre-existing organ failure
  • Failure to obtain initial bile aspiration
  • Failed PTBD
  • Failure of full drainage via PTBD (all of the bile duct obstruction should be drained via PTBD)
  • Organ failure from other causes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02601417
Other Study ID Numbers  ICMJE 2015-1452
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Hyub Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Hyub Lee, MD. PhD. Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea
PRS Account Seoul National University Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP