PeritonitisNCT04594421
Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis
An observational study of Peritonitis, run by Peking University First Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Peritonitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2021to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients on peritoneal dialysis
Who may be able to join
- 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
Who cannot join
- Those who cannot be followed up regularly
- Reluctant to join this researcher
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renal Division and Institute of Nehprology,Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jie Dong, MD, 086-010-83572388, jie.dong@bjmu.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Peritonitis
- Keywords
- Peritonitis, eosinophil, peritoneal dialysis
- Medical subject headings
- Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of elevated eosinophils in peritoneal dialysis effluent
eosinophil number >100 /mm3, or the proportion of polynuclear leukocytes >10%.
Measured: Feb 18,2021 to December 31,2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start18 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594421
- Sponsor's protocol ID
- Eosinophil increase
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2020
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Increasing Proportion and Change Trend of Eosinophil in Peritoneal Fluid During Peritoneal Dialysis-Related Peritonitis
- ClinicalTrials.gov ID
- NCT04594421
- Acronym / sponsor ID
- Eosinophil increase
- Conditions
- Peritonitis
- Keywords
- Peritonitis, eosinophil, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients on peritoneal dialysis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Those who cannot be followed up regularly
- Reluctant to join this researcher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of elevated eosinophils in peritoneal dialysis effluent
Time frame: Feb 18,2021 to December 31,2023
eosinophil number >100 /mm3, or the proportion of polynuclear leukocytes >10%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiantian Ma (15201286467, matiantian1986@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of elevated eosinophils in peritoneal dialysis effluent (time frame: Feb 18,2021 to December 31,2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.