A Phase 4 interventional study of endotoxin assay in peritoneal dialysis effluent in Peritoneal Dialysis Associated Peritonitis, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-07-28.
Sponsored by Chinese University of Hong Kong · Phase 4, Interventional, and Diagnostic
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.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's enrollment of 325 is above the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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at least two of the followings:
Exclusion Criteria:
endotoxin assay in peritoneal dialysis effluent
Other: endotoxin assay in peritoneal dialysis effluent
endotoxin level by Limulus Amebocyte Lysate (LAL) assay
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).
Time frame: 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.
Time frame: 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.
Time frame: 6 months
conversion to long-term hemodialysis
Time frame: 6 months
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
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong