Clinical Trial: The Necessity of Bile Cultures in Patients With Acute Cholangitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: August 27, 2015
Date Started: August 2015
Date Completion: February 2019
Last Updated: November 8, 2015
Last Verified: November 2015