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

Not Applicable

Completed

• Conditions: Peritonitis
• Interventions: Diagnostic Test: Periplex

• Registration Number: NCT04070196
• Lead Sponsor: Singapore General Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Study Start: 2019-09-25
• Primary Completion: 2023-06-24
• Study Completion: 2024-02-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leucocyte testing	Periplex	The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis.

Primary Outcome Measures

Name	Time	Method
Test positive for peritonitis	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 Outcome Measures

Name	Time	Method
causal organisms for peritonitis	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
resolution of peritonitis	within 2 weeks of completion of a course of antibiotics for peritonitis	Number of participants having negative test result for peritonitis

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore