An interventional study of Periplex in Peritonitis, sponsored by Singapore General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's enrollment of 120 is above the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Singapore General Hospital is the lead sponsor of 270 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
Test positive for peritonitis
Number of participants having positive test result for peritonitis
Time frame: within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.
resolution of peritonitis
Number of participants having negative test result for peritonitis
Time frame: 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
Time frame: within a week of peritonitis
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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