Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Primary Purpose
Peritoneal Dialysis Associated Peritonitis
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
endotoxin assay in peritoneal dialysis effluent
Sponsored by
About this trial
This is an interventional diagnostic trial for Peritoneal Dialysis Associated Peritonitis focused on measuring renal failure, survival, peritoneal failure
Eligibility Criteria
Inclusion Criteria:
at least two of the followings:
- abdominal pain or cloudy PD effluent;
- leukocytosis in PD effluent (WBC > 100/ml); and
- positive Gram-stain or culture from PD effluent
Exclusion Criteria:
- mycobacterial peritonitis
- obvious surgical problems and require laparotomy
Sites / Locations
- Department of Medicine, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
endotoxin assay in peritoneal dialysis effluent
Outcomes
Primary Outcome Measures
relapsing peritonitis
Relapsing peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode with the same organism (or culture negative in the second episode).
recurrent peritonitis
Recurrent peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode but with a different organism.
repeat peritonitis
Repeat peritonitis will be defined as an episode that occurs more than 4 weeks after completion of therapy of a prior episode with the same organism.
conversion to long-term hemodialysis
Secondary Outcome Measures
peritonitis that requires hospitalization
catheter removal
death due to peritonitis
all cause mortality
Full Information
NCT ID
NCT01817309
First Posted
March 19, 2013
Last Updated
July 27, 2016
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01817309
Brief Title
Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Official Title
Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A reliable predictor of relapsing peritonitis is invaluable in the management of PD peritonitis. Recent studies showed that bacterial-derived lipopolysaccharide (LPS) fragments are present in clinically used fluids such as dialysis fluid. LPS are thought to be derived from microorganisms inhabiting body fluid. The investigators hypothesize that the presence of LPS in PD effluent is a predictor of relapsing peritonitis in PD patients. The investigators plan to study 300 patients with PD peritonitis. After inform consent, specimens of PD effluent will be collected on the day of initiating antibiotic treatment, every 5 days until the day of completing antibiotic treatment, and then 28 days later for the test of LPS level. All patients will be followed for one year after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study would explore the use of detecting LPS in PD effluent as a non-invasive tests for the prediction of relapsing peritonitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis Associated Peritonitis
Keywords
renal failure, survival, peritoneal failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
endotoxin assay in peritoneal dialysis effluent
Intervention Type
Other
Intervention Name(s)
endotoxin assay in peritoneal dialysis effluent
Intervention Description
endotoxin level by Limulus Amebocyte Lysate (LAL) assay
Primary Outcome Measure Information:
Title
relapsing peritonitis
Description
Relapsing peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode with the same organism (or culture negative in the second episode).
Time Frame
1 month
Title
recurrent peritonitis
Description
Recurrent peritonitis will be defined as an episode that occurs within 4 weeks of completion of therapy of a prior episode but with a different organism.
Time Frame
1 month
Title
repeat peritonitis
Description
Repeat peritonitis will be defined as an episode that occurs more than 4 weeks after completion of therapy of a prior episode with the same organism.
Time Frame
6 months
Title
conversion to long-term hemodialysis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
peritonitis that requires hospitalization
Time Frame
6 months
Title
catheter removal
Time Frame
6 months
Title
death due to peritonitis
Time Frame
6 months
Title
all cause mortality
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least two of the followings:
abdominal pain or cloudy PD effluent;
leukocytosis in PD effluent (WBC > 100/ml); and
positive Gram-stain or culture from PD effluent
Exclusion Criteria:
mycobacterial peritonitis
obvious surgical problems and require laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk Chun Szeto, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
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