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

This study is currently recruiting participants.
Verified October 2013 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01817309
First received: March 19, 2013
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Peritoneal Dialysis Associated Peritonitis
Other: endotoxin assay in peritoneal dialysis effluent
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • relapsing peritonitis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • conversion to long-term hemodialysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • peritonitis that requires hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • catheter removal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • death due to peritonitis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • all cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
endotoxin assay in peritoneal dialysis effluent
Other: endotoxin assay in peritoneal dialysis effluent
endotoxin level by Limulus Amebocyte Lysate (LAL) assay

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817309

Contacts
Contact: Cheuk Chun Szeto, MD 852-2632-3878 ccszeto@cuhk.edu.hk
Contact: Bonnie CH Kwan, MBBS 852-2632-3528 bonniekwan@cuhk.edu.hk

Locations
Hong Kong
Department of Medicine, Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Cheuk Chun Szeto, MD    852-2632-3878    ccszeto@cuhk.edu.hk   
Contact: Bonnie CH Kwan, MBBS    852-2632-3528    bonniekwan@cuhk.edu.hk   
Principal Investigator: Cheuk Chun Szeto, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk Chun Szeto, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01817309     History of Changes
Other Study ID Numbers: BLPS
Study First Received: March 19, 2013
Last Updated: October 15, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
renal failure
survival
peritoneal failure

Additional relevant MeSH terms:
Peritonitis
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 22, 2014