Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis

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

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

Study Overview

• Status: Recruiting
• Conditions: Peritonitis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tiantian Ma; Phone Number: 15201286467; Email: matiantian1986@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Renal Division and Institute of Nehprology,Peking University First Hospital
      • Contact: Jie Dong, MD; Phone Number: 086-010-83572388; Email: jie.dong@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients on peritoneal dialysis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: peritoneal dialysis; Peritonitis; eosinophil
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: Eosinophil increase

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No