Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients

Overview

Peritoneal dialysis (PD) is a home-based dialysis therapy and peritonitis is a serious complication in PD. A reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in PD patients. The study aims to examine the effectiveness of Periplex®, point-of-care test, in the diagnosis of peritonitis in PD patients.

Full Title of Study: “Rapid Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 24, 2023

Detailed Description

A reliable point-of-care test to detect peritonitis is indeed needed for early diagnosis of peritonitis at home and seeking medical help early. We hypothesize that Periplex® is not inferior to routine leukocyte testing of PD Fluid effluent in the diagnosis of peritonitis. The test strip is designed to detect the inflammatory markers (IL6 and MMP-8) which are usually released during peritonitis. The strip is intended to be used in the PD patients who suspected to have symptoms of peritonitis. The target population is all adult PD patients who are followed up in Singapore General Hospital and have signs and symptoms suspected of peritonitis during the study period. The test is considered positive for peritonitis if one or both test lines appear in the window of the test strip. The test will be performed at 2-time points, one at the presentation of peritonitis and one at the completion of antibiotics for the current episode of peritonitis, to document resolution of peritonitis. The results of the tests will be compared with the leukocyte testing of PD effluent.

Interventions

  • Diagnostic Test: Periplex
    • Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent

Arms, Groups and Cohorts

  • Other: Leucocyte testing
    • The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis.

Clinical Trial Outcome Measures

Primary Measures

  • Test positive for peritonitis
    • Time Frame: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.
    • Number of participants having positive test result for peritonitis

Secondary Measures

  • resolution of peritonitis
    • Time Frame: within 2 weeks of completion of a course of antibiotics for peritonitis
    • Number of participants having negative test result for peritonitis
  • causal organisms for peritonitis
    • Time Frame: within a week of peritonitis
    • Number of participants with gram-positive organisms, gram-negative organisms, no bacterial growth or other organisms peritonitis having test result positive for peritonitis

Participating in This Clinical Trial

Inclusion Criteria

  • Adult PD patients who are followed up in Singapore General Hospital and presented with signs and symptoms suspected of peritonitis including fever, abdominal pain or cloudy effluent will be recruited for the study. Exclusion Criteria:

  • 1. PD patients who are not followed up in SGH 2. Patients with mentally challenging conditions and who are unable to provide a valid consent 3. Non-PD patients 4. PD patients who do not have signs or symptoms suspected of peritonitis

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Singapore General Hospital
  • Collaborator
    • Mologic Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Htay Htay, FRCP, 63214436, htay.htay@singhealth.com.sg

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.