Endotoxin-associated Sterile Peritonitis Clinical Trial
Official title:
e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study
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.
e-STEPS is an observational, non-interventional, retrospective review study of healthcare
medical records conducted in PD units at approximately 12 sites in The Netherlands, Germany,
Hungary, Portugal, and the UK. There will be no study drug or any other medical intervention
involved. Furthermore, no patient-identifying information will be transferred to the Study
Coordinating Centre (SCC) or the sponsor. Medical records of cases with e-SP, BP and NoP who
meet the proposed study selection criteria will be selected from approximately 12 study
sites identified across the 5 European countries.
Each case identified by site study staff as potentially eligible for enrollment into the
study will be entered into the case disposition log (CDL) and will be assigned a unique
site-specific study identification number. These cases will be considered the study sampling
frame. The SCC will select a preliminary target cohort of subjects from the sampling frame
by selecting all e-SP cases and undertaking a random sample of NoP and BP cases within site
to ensure 1:1:1 enrollment ratio between the 3 study groups. In the event that a sampling
frame at a given site contains less NoP or BP cases when compared to e-SP cases, all NoP or
BP cases will be selected for enrollment into the study and additional cases will be
randomly selected from another site within the country to make up for the deficit if
sampling frames allow. Sampling within site or alternatively within country ensures that NoP
cases are matched to e-SP cases by lot of recalled PD solution. Cases within The
Netherlands, Portugal and the UK all used the same recalled lot of PD solutions. Therefore,
if within site and within country sampling cannot be achieved, across country sampling can
be undertaken in these 3 countries. If it is determined that all e-SP and NoP cases in the
sampling frame were on CAPD at the time of the index event, any BP cases identified in the
sampling frame on APD at the time of index event may be excluded from the selection process
(may not be selected to comprise the preliminary target cohort) and would therefore not be
enrolled into the study.
Local site study staff will review the medical records of the cases included in the
preliminary target cohort to confirm eligibility. Those cases meeting the eligibility
criteria will comprise the final study cohort and will be enrolled into the study as
subjects.
Pseudonymised data from the subjects' medical records will be abstracted by local site study
staff and entered at the site into the secured pass-word protected electronic data capture
(EDC) system. No patient-identifying information will be available to non-site staff; (i.e.,
representatives of the SCC and the study sponsor). Over the course of the study, as data are
entered, the case status page within the EDC system will automatically update the study
disposition of each case. As the data will be automatically quality controlled at the point
of data entry into the EDC system on the basis of programmed validation rules for each of
the study variables, quality control and query resolution can be managed remotely.
Therefore, site data monitoring visits by the SCC are not envisioned. No patient-identifying
information will be entered into the EDC system; as such, neither the SCC nor the study
sponsor will be able to identify subjects as actual patients.
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Observational Model: Cohort, Time Perspective: Retrospective