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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817309

Enrollment

325

Registered

2013-03-25

Start date

2013-06-30

Completion date

2015-04-30

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis Associated Peritonitis

Keywords

renal failure, survival, peritoneal failure

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.

Interventions

OTHERendotoxin assay in peritoneal dialysis effluent

endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
conversion to long-term hemodialysis	6 months	—
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.

Secondary

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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026