CompletedNot Applicable

e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

Germany, Hungary, Netherlands127 participantsStarted 2011-12

Plain-language summary

This observational retrospective healthcare medical record review study is to evaluate and differentiate the clinical characteristics and outcomes in peritoneal dialysis (PD) patients with either endotoxin-associated sterile peritonitis (e-SP), bacterial peritonitis (BP) or no peritonitis (NoP) over a 12-15 month period from dialysis clinics in The Netherlands, Germany, Hungary, Portugal, and the United Kingdom (UK). The primary study objectives are to: * Describe changes in the peritoneal membrane function and clinical outcomes over time between e-SP, BP and NoP PD patients. * Describe and differentiate clinical characteristics during the acute clinical presentation of e-SP and BP. The secondary study objective is to: \- Generate a dataset that will facilitate post hoc exploratory hypothesis-generation related to clinical and resource utilisation (RU) outcomes in association with e-SP.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Bacterial peritonitis (BP) subgroup
.1. Inclusion criteria
.2. Exclusion criteria
. No peritonitis (NoP) subgroup
.1. Inclusion criteria
.2. Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Describe changes in the peritoneal membrane function and clinical outcomes over time between endotoxin associated peritonitis (e-SP), bacterial peritonitis (BP) and no peritonitis (NoP) peritoneal dialysis (PD) patients.

Timeframe: Data will be analysed at 4 time points: baseline, index event, 6±3 months post date of index event, and 12±3 months post date of index event.

Trial details

NCT IDNCT01460056

SponsorBaxter Healthcare Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-06

View on ClinicalTrials.gov More Endotoxin-associated Sterile Peritonitis trials