Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis
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| ClinicalTrials.gov Identifier: NCT01817309 |
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Recruitment Status :
Completed
First Posted : March 25, 2013
Last Update Posted : July 28, 2016
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Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peritoneal Dialysis Associated Peritonitis | Other: endotoxin assay in peritoneal dialysis effluent | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 325 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis |
| Study Start Date : | June 2013 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Study group
endotoxin assay in peritoneal dialysis effluent
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Other: endotoxin assay in peritoneal dialysis effluent
endotoxin level by Limulus Amebocyte Lysate (LAL) assay |
Primary Outcome Measures :
- relapsing peritonitis [ Time Frame: 1 month ]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 [ Time Frame: 1 month ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]
Secondary Outcome Measures :
- peritonitis that requires hospitalization [ Time Frame: 6 months ]
- catheter removal [ Time Frame: 6 months ]
- death due to peritonitis [ Time Frame: 6 months ]
- all cause mortality [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT01817309
Locations
| Hong Kong | |
| Department of Medicine, Prince of Wales Hospital | |
| Shatin, Hong Kong | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Cheuk Chun Szeto, MD | Chinese University of Hong Kong |
| Responsible Party: | Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01817309 History of Changes |
| Other Study ID Numbers: |
BLPS |
| First Posted: | March 25, 2013 Key Record Dates |
| Last Update Posted: | July 28, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
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renal failure survival peritoneal failure |
Additional relevant MeSH terms:
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Peritonitis Intraabdominal Infections Infection Peritoneal Diseases Digestive System Diseases |