Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis

Study Overview
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Brief Summary
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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.

Official Title
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Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis

Conditions
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Peritoneal Dialysis Associated Peritonitis

Intervention / Treatment
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* Other: endotoxin assay in peritoneal dialysis effluent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>endotoxin assay in peritoneal dialysis effluent | Other: endotoxin assay in peritoneal dialysis effluent<br>* endotoxin level by Limulus Amebocyte Lysate (LAL) assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 month | 
| 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. | 1 month | 
| 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. | 6 months | 
| conversion to long-term hemodialysis |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritonitis that requires hospitalization |  | 6 months | 
| catheter removal |  | 6 months | 
| death due to peritonitis |  | 6 months | 
| all cause mortality |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal failure, survival, peritoneal failure