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

Phase 4

Completed

• Conditions: Peritoneal Dialysis Associated Peritonitis
• Interventions: Other: endotoxin assay in peritoneal dialysis effluent

• Registration Number: NCT01817309
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-25
• Study Start: 2013-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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

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Exclusion Criteria

• mycobacterial peritonitis
• obvious surgical problems and require laparotomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	endotoxin assay in peritoneal dialysis effluent	endotoxin assay in peritoneal dialysis effluent

Primary Outcome Measures

Name	Time	Method
relapsing peritonitis	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	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	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	6 months

Secondary Outcome Measures

Name	Time	Method
peritonitis that requires hospitalization	6 months
catheter removal	6 months
death due to peritonitis	6 months
all cause mortality	6 months

Trial Locations

Locations (1)

Department of Medicine, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong