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Completed

NCT Number: NCT04070196

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

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.

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Key information

Conditions

Peritonitis Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169856

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periplex

Diagnostic Test

Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent

Primary outcomes

  1. Test positive for peritonitis

    Time frame: 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 outcomes

  1. resolution of peritonitis

    Time frame: within 2 weeks of completion of a course of antibiotics for peritonitis

    Number of participants having negative test result for peritonitis

  2. causal organisms for peritonitis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Mologic Ltd

Registry information

Official study title

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

Acronym: Periplex

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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