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

Peritoneal Dialysis Associated Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817309
• Other study ID #: BLPS
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2013
• Last updated: July 27, 2016
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peritoneal Dialysis Associated Peritonitis
• Peritonitis

Intervention

Other:
• endotoxin assay in peritoneal dialysis effluent
endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	conversion to long-term hemodialysis		6 months	No
Secondary	peritonitis that requires hospitalization		6 months	No
Secondary	catheter removal		6 months	No
Secondary	death due to peritonitis		6 months	Yes
Secondary	all cause mortality		6 months	Yes