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OpenTrials
Completed

NCT Number: NCT01817309

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine, Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • mycobacterial peritonitis
  • obvious surgical problems and require laparotomy

Treatment and study plan

endotoxin assay in peritoneal dialysis effluent

Other

endotoxin level by Limulus Amebocyte Lysate (LAL) assay

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. conversion to long-term hemodialysis

    Time frame: 6 months

Secondary outcomes

  1. peritonitis that requires hospitalization

    Time frame: 6 months

  2. catheter removal

    Time frame: 6 months

  3. death due to peritonitis

    Time frame: 6 months

  4. all cause mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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