Clinical Trial: e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

Brief 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.


Detailed Summary:

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
Sponsor: Baxter Healthcare Corporation

Current 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).


Original Primary Outcome: Describe changes in the peritoneal membrane function and clinical outcomes over time between e-SP, BP and NoP 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).


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baxter Healthcare Corporation

Dates:
Date Received: October 24, 2011
Date Started: December 2011
Date Completion:
Last Updated: January 31, 2013
Last Verified: January 2013