Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis

Peritonitis Clinical Trial

Official title:

Study on the Increasing Proportion and Change Trend of Eosinophil in Peritoneal Fluid During Peritoneal Dialysis-Related Peritonitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594421
• Other study ID #: Eosinophil increase
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2021
• Source: Peking University First Hospital
• Contact: Tiantian Ma
• Phone: 15201286467
• Email: matiantian1986[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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. In this study, 100 patients with peritoneal dialysis-associated peritonitis who meet the inclusion criteria will be selected. Demographic data, laboratory variables, peritoneal fluid cytology and bacterial culture will be collected within 24 hours of peritonitis (day 1). Peritoneal fluid cytology includes leukocyte classification and eosinophilic leukocyte count will be examined at day 3, 5, 7, 10, 14, 21, 30, 60 and 90 after peritonitis. All patients will be followed up for 90 days, and their peritonitis outcome will be recorded. The primary endpoint is the prevalence of eosinophil increase in peritoneal effluent, which is defined as >100 eosinophils/mm^3, or >10% eosinophils of the total non-erythrocyte count. Secondary end points are peritonitis outcome at month 1 and 3 including transfer to hemodialysis , death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Those who cannot be followed up regularly

• Reluctant to join this researcher

Related Conditions & MeSH terms

• Peritonitis

Locations

Country	Name	City	State
China	Renal Division and Institute of Nehprology,Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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