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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01817309
First Posted: March 25, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bacteria Endotoxin in Peritoneal Dialysis Effluent as a Predictor of Relapsing, Recurrent, and Repeat Peritonitis

Further study details as provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:

Primary Outcome Measures:
  • relapsing peritonitis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

  • conversion to long-term hemodialysis [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • peritonitis that requires hospitalization [ Time Frame: 6 months ]
  • catheter removal [ Time Frame: 6 months ]
  • death due to peritonitis [ Time Frame: 6 months ]
  • all cause mortality [ Time Frame: 6 months ]

Enrollment: 325
Study Start Date: June 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817309


Locations
Hong Kong
Department of Medicine, Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk Chun Szeto, MD Chinese University of Hong Kong
  More Information

Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01817309     History of Changes
Other Study ID Numbers: BLPS
First Submitted: March 19, 2013
First Posted: March 25, 2013
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
renal failure
survival
peritoneal failure

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases