Peritonitis
Conditions
Keywords
Peritonitis, point-of-care test, Peritoneal Dialysis
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.
Interventions
DIAGNOSTIC_TESTPeriplex
Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent
Sponsors
Mologic Ltd
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| resolution of peritonitis | 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 | 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 |
Countries
Singapore
Outcome results
None listed