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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Study group; endotoxin assay in peritoneal dialysis effluent	Other: endotoxin assay in peritoneal dialysis effluent; endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Outcome Measures

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Primary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. conversion to long-term hemodialysis [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. peritonitis that requires hospitalization [ Time Frame: 6 months ]
2. catheter removal [ Time Frame: 6 months ]
3. death due to peritonitis [ Time Frame: 6 months ]
4. all cause mortality [ Time Frame: 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Exclusion Criteria:

• mycobacterial peritonitis
• obvious surgical problems and require laparotomy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	July 28, 2016
Last Verified:	July 2016

Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:

renal failure; survival; peritoneal failure

Additional relevant MeSH terms:

Peritonitis; Intraabdominal Infections; Infection; Peritoneal Diseases; Digestive System Diseases