NCT04594421

Brief Summary

A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. This study will provide evidence for routine eosinophil testing

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

October 13, 2020

Last Update Submit

November 24, 2021

Conditions

Peritonitis

Keywords

Peritonitiseosinophilperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Prevalence of elevated eosinophils in peritoneal dialysis effluent

    eosinophil number \>100 /mm3, or the proportion of polynuclear leukocytes \>10%.

    Feb 18,2021 to December 31,2023

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients on peritoneal dialysis

You may qualify if:

  • Diagnosed as peritoneal dialysis-related peritonitis;
  • Age\> 14 years
  • Maintenance peritoneal dialysis due to end-stage renal failure ≥3 months
  • Use of lactate glucose dialysate

You may not qualify if:

  • Those who cannot be followed up regularly
  • Reluctant to join this researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Division and Institute of Nehprology,Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Central Study Contacts

Tiantian Ma

CONTACT

15201286467matiantian1986@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Renal Divison,Department of Medicine

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

February 18, 2021

Primary Completion

December 31, 2023

Study Completion

April 1, 2024

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations

CN(1)