Clinical trial NCT04070196: Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Official title: Rapid Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis
Keywords: Peritonitis
point-of-care test
Peritoneal Dialysis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Mologic Ltd
First posted: 2019-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test positive for peritonitis
timeFrame: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.
Secondary outcomes:
measure: resolution of peritonitis
timeFrame: within 2 weeks of completion of a course of antibiotics for peritonitis
measure: causal organisms for peritonitis
timeFrame: within a week of peritonitis
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: