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

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

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.

Study Overview

• Status: Completed
• Conditions: Peritonitis
• Intervention / Treatment: Diagnostic test: Periplex

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169856
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Leucocyte testing; The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Mologic Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): June 24, 2023
• Study Completion (Actual): February 24, 2024

Study Registration Dates

• First Submitted: August 18, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; point-of-care test; Peritonitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: 2018/3152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No