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

Peritonitis Clinical Trial

— Periplex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070196
• Other study ID #: 2018/3152
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: February 24, 2024

Study information

• Verified date: April 2024
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 24, 2024
• Est. primary completion date: June 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Mologic Ltd

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	resolution of peritonitis	Number of participants having negative test result for peritonitis	within 2 weeks of completion of a course of antibiotics for peritonitis
Secondary	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