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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis Associated Peritonitis
• Intervention / Treatment: Other: endotoxin assay in peritoneal dialysis effluent

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Department of Medicine, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Cheuk Chun Szeto, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 25, 2013

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: survival; renal failure; peritoneal failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: BLPS