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

Primary Purpose

Peritonitis

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Periplex
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peritonitis focused on measuring Peritonitis, point-of-care test, Peritoneal Dialysis

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Leucocyte testing

Arm Description

The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis.

Outcomes

Primary Outcome Measures

Test positive for peritonitis
Number of participants having positive test result for peritonitis

Secondary Outcome Measures

resolution of peritonitis
Number of participants having negative test result 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

Full Information

First Posted
August 18, 2019
Last Updated
November 23, 2022
Sponsor
Singapore General Hospital
Collaborators
Mologic Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04070196
Brief Title
Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Acronym
Periplex
Official Title
Rapid Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
January 24, 2023 (Anticipated)
Study Completion Date
June 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Mologic Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
Keywords
Peritonitis, point-of-care test, Peritoneal Dialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leucocyte testing
Arm Type
Other
Arm Description
The PD effluent will be sent to the laboratory for leucocyte testing for patients presented with suspected PD peritonitis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Periplex
Intervention Description
Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent
Primary Outcome Measure Information:
Title
Test positive for peritonitis
Description
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.
Secondary Outcome Measure Information:
Title
resolution of peritonitis
Description
Number of participants having negative test result for peritonitis
Time Frame
within 2 weeks of completion of a course of antibiotics for peritonitis
Title
causal organisms for peritonitis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Htay Htay, FRCP
Phone
63214436
Email
htay.htay@singhealth.com.sg
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Htay Htay, FRCP(Edin)
Phone
63214436
Email
htay.htay@singhealth.com.sg

12. IPD Sharing Statement

Learn more about this trial

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

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