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

This study is ongoing, but not recruiting participants.

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: February 4, 2015

Last verified: February 2015

History of Changes

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:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

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:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:	February 4, 2015
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 Digestive System Diseases Infection Intraabdominal Infections Peritoneal Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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