Endotoxin-associated Sterile Peritonitise-STEPSNCT01460056
e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study
An observational study of Endotoxin-associated Sterile Peritonitis, run by Baxter Healthcare Corporation at 12 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotoxin-associated Sterile Peritonitis
- How many people
- 127 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Dec 2011to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects will be incident cases of endotoxin-associated peritonitis (e-SP) and bacterial peritonitis (BP) and no peritonitis (NoP) who meet all of the study eligibility criteria during the study eligibility period.
- Endotoxin-associated peritonitis (e-SP) subgroup: 1.1. Inclusion Criteria:
- On continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) at time of index event.
- Used 1 of 3 Baxter PD solutions recalled lots (Nutrineal 10G12G44, Nutrineal 10I13G42, or Dianeal 10I20G44) between 1 August 2010 and 31 December 2010.
- Has a documented diagnosis of e-SP (index event) between 1 August 2010 and 31 December 2010, defined as meeting 1 of the 2 criteria listed below:
- Cloudy PD effluent with an increased peritoneal leukocyte count >100 mm3 and a negative bacterial culture; or
- Cloudy PD effluent which resolves without the use of antibiotics and with the discontinuation of the Baxter PD solutions recalled lot within 24 hours.
- Aged 18 years or older at time of index event. 1.2. Exclusion Criteria:
- Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
- Had a diagnosis of fungal peritonitis at the index event.
- Received antibiotics for the treatment of other infectious ailments within 1 week prior to the e-SP index event.
- Received antibiotics for the treatment of peritonitis (index event) prior to the collection of cloudy PD effluent for cell count and cultures.
- Had a diagnosis of bacterial peritonitis (BP) within 3 months prior to the e-SP index event.
- Pregnancy during the applicable study period (from index event to 12-15 months post index event).
- Bacterial peritonitis (BP) subgroup 2.1. Inclusion criteria
- On CAPD or APD at time of index event.
- Used Baxter's PD solutions lots manufactured by Baxter (Dianeal, Extraneal, Nutrineal in Viaflex containers) between 1 December 2008 and 30 November 2010.
- Had a documented diagnosis of BP (index event), between 1 December 2008 and 31 December 2010, defined as meeting the 2 criteria listed below:
- Cloudy peritoneal dialysis (PD) effluent with an increased peritoneal leukocyte count >100 mm3;
- Positive bacterial culture with a causative organism(s).
- Aged 18 year or older at time of index event. 2.2. Exclusion criteria
- Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
- Had a diagnosis of e-SP between 1 August 2010 and 31 December 2010.
- Had a diagnosis of fungal peritonitis at the index event.
- Pregnancy during the applicable study period (from index event to 12-15 months post index event).
- No peritonitis (NoP) subgroup
3.1. Inclusion criteria
- On CAPD or APD at time of index event.
- Used 1 of 3 Baxter PD solution recalled lots (Nutrineal 10G12G44, Nutrineal 10I13G42, or Dianeal 10I20G44) between 1 August 2010 and 31 December 2010.
- Aged 18 year or older at time of index event.
3.2. Exclusion criteria
- Had a documented diagnosis of any type of peritonitis between 1 August 2010 and 31 December 2010.
- Participation in an interventional clinical study (i.e., therapy or dietary interventions) during the applicable study period (from index event to 12-15 months post index event).
- Pregnancy during the applicable study period (from index event to 12-15 months post index event).
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany3 sites
Dialysepraxis Dessau
Dessau, 06847
Dialysezentrum Würzburg
Würzburg, 97072
Dialysezentrum Zwickau
Zwickau, 08060
Hungary3 sites
B.Braun Avitum Zrt. 11 . sz. Dialízisközpont
Győr, 9023
B.Braun Avitum Zrt. 06 . sz. Dialízisközpont
Szombathely, 9700
B.Braun Avitum Zrt. 03 . sz. Dialízisközpont
Veszprém, 8200
Netherlands3 sites
Catharina ziekenhuis
Eindhoven, 25623
Medisch centrum Haaglanden
The Hague, 2512
Zaans Medisch Centrum
Zaandam, 1502
Portugal2 sites
Hospital Évora
Evora, 7000-811
Hospital Sao Joao
Porto, 4200 - 319
About this 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Endotoxin-associated Sterile Peritonitis
- Keywords
- peritoneal dialysis, endotoxin-associated sterile peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Data including but not limited to demographics, comorbidities, clinical characteristics and outcomes, blood and urine laboratory studies, adequacy and peritoneal membrane function tests, PD prescriptions, empiric antibiotic usage, hospitalisations, outpatient visits, and accident and emergency visits will be collected (retropspective).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotoxin-associated Sterile PeritonitisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cory Sise, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460056
- Sponsor's protocol ID
- M-11378-001
- Acronym
- e-STEPS
- Status last verified
- Jan 2013
- First submitted
- 24 Oct 2011
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study
- ClinicalTrials.gov ID
- NCT01460056
- Acronym / sponsor ID
- e-STEPS / M-11378-001
- Conditions
- Endotoxin-associated Sterile Peritonitis
- Keywords
- peritoneal dialysis, endotoxin-associated sterile peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Oct 2011 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects will be incident cases of endotoxin-associated peritonitis (e-SP) and bacterial peritonitis (BP) and no peritonitis (NoP) who meet all of the study eligibility criteria during the study eligibility period.
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
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.
Time frame: 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.
Data including but not limited to demographics, comorbidities, clinical characteristics and outcomes, blood and urine laboratory studies, adequacy and peritoneal membrane function tests, PD prescriptions, empiric antibiotic usage, hospitalisations, outpatient visits, and accident and emergency visits will be collected (retropspective).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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.
Cory Sise, MD study director
Baxter Healthcare Corporation
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endotoxin-associated Sterile Peritonitis, run by Baxter Healthcare Corporation at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Hungary, Netherlands, Portugal, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). 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 1 Feb 2013.