NCT04070196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

August 18, 2019

Last Update Submit

April 29, 2024

Conditions

Peritonitis

Keywords

Peritonitispoint-of-care testPeritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Test positive for peritonitis

    Number of participants having positive test result for peritonitis

    within 24 hours of presentation with signs and symptoms suspected of peritonitis in PD patients.

Secondary Outcomes (2)

  • resolution of peritonitis

    within 2 weeks of completion of a course of antibiotics for peritonitis

  • causal organisms for peritonitis

    within a week of peritonitis

Study Arms (1)

Leucocyte testing

OTHER

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

Diagnostic Test: Periplex

Interventions

PeriplexDIAGNOSTIC_TEST

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

Leucocyte testing

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2019

First Posted

August 28, 2019

Study Start

September 25, 2019

Primary Completion

June 24, 2023

Study Completion

February 24, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations

SG(1)