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

NCT01817309 | Completed Phase 4

• 1 other identifier: BLPS
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis Associated Peritonitis

Keywords

renal failure; survival; peritoneal failure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• peritonitis that requires hospitalization

  6 months

• catheter removal

  6 months

• death due to peritonitis

  6 months

• all cause mortality

  6 months

Study Arms (1)

Study group

EXPERIMENTAL

endotoxin assay in peritoneal dialysis effluent

Other: endotoxin assay in peritoneal dialysis effluent

Interventions

endotoxin assay in peritoneal dialysis effluent OTHER

endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Study group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least two of the followings:
• abdominal pain or cloudy PD effluent;
• leukocytosis in PD effluent (WBC \> 100/ml); and
• positive Gram-stain or culture from PD effluent

You may not qualify if:

• mycobacterial peritonitis
• obvious surgical problems and require laparotomy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Cheuk Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 25, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

HK (1)