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Trial record 3 of 64 for:    "Bile Duct Disease" | "Anti-Infective Agents"

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

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.

Condition or disease Intervention/treatment Phase
Acute Cholangitis Other: Ignoring result of bile culture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Necessity of Bile Cultures in Patients With Acute Cholangitis
Actual Study Start Date : August 27, 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
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
Other: Ignoring result of bile culture
Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hospital days [ Time Frame: Expected average of 7 days ]
  2. Re-intervention for biliary drainage [ Time Frame: Expected average of 2 days ]
  3. Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601417


Contacts
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Contact: Sang Hyub Lee, MD. PhD. +82-2-2072-4892 gidoctor@snuh.org
Contact: Jae Woo Lee, MD. +82-10-9411-6446 planeswalk6446@daum.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang Hyub Lee, MD. PhD.    +82-2-2072-4892    gidoctor@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Sang Hyub Lee, MD. PhD. Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea

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Responsible Party: Sang Hyub Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02601417     History of Changes
Other Study ID Numbers: 2015-1452
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Keywords provided by Sang Hyub Lee, Seoul National University Hospital:
Cholangitis
Bile culture
Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents