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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-04-30

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.

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Detailed Description

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Conditions

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Peritoneal Dialysis Associated Peritonitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

endotoxin assay in peritoneal dialysis effluent

Group Type EXPERIMENTAL

endotoxin assay in peritoneal dialysis effluent

Intervention Type OTHER

endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Interventions

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endotoxin assay in peritoneal dialysis effluent

endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

at least two of the followings:

1. abdominal pain or cloudy PD effluent;
2. leukocytosis in PD effluent (WBC \> 100/ml); and
3. positive Gram-stain or culture from PD effluent