The Necessity of Bile Cultures in Patients With Acute Cholangitis
Primary Purpose
Acute Cholangitis
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ignoring result of bile culture
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholangitis focused on measuring Cholangitis, Bile culture
Eligibility 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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Trial
Arm Description
Group which considers both blood culture and bile culture for antibiotics choice
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
Outcomes
Primary Outcome Measures
Organ Failure
Shock
Systolic blood pressure under 90mmHg after adequate volume resuscitation
Vassopressors or inotropics needed to maintain effective circulation
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
Altered mentality
Glasgow coma scale (GCS) < 12
or GCS score decrease > 3
Acute respiratory distress
Pulse oxygen saturation < 90%
Mechanical ventilation applied
Secondary Outcome Measures
Hospital days
Re-intervention for biliary drainage
Mortality
Full Information
NCT ID
NCT02601417
First Posted
August 27, 2015
Last Updated
September 5, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02601417
Brief Title
The Necessity of Bile Cultures in Patients With Acute Cholangitis
Official Title
The Necessity of Bile Cultures in Patients With Acute Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholangitis
Keywords
Cholangitis, Bile culture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group which considers both blood culture and bile culture for antibiotics choice
Arm Title
Trial
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Ignoring result of bile culture
Intervention Description
Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.
Primary Outcome Measure Information:
Title
Organ Failure
Description
Shock
Systolic blood pressure under 90mmHg after adequate volume resuscitation
Vassopressors or inotropics needed to maintain effective circulation
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
Altered mentality
Glasgow coma scale (GCS) < 12
or GCS score decrease > 3
Acute respiratory distress
Pulse oxygen saturation < 90%
Mechanical ventilation applied
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Hospital days
Time Frame
Expected average of 7 days
Title
Re-intervention for biliary drainage
Time Frame
Expected average of 2 days
Title
Mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snuh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Woo Lee, MD.
Phone
+82-10-9411-6446
Email
planeswalk6446@daum.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Organizational Affiliation
Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snuh.org
12. IPD Sharing Statement
Learn more about this trial
The Necessity of Bile Cultures in Patients With Acute Cholangitis
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