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e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

NCT01460056 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2013-02-01

No results posted yet for this study

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.

Conditions

  • Endotoxin-associated Sterile Peritonitis

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Cory Sise, MD · Baxter Healthcare Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • Germany
  • Hungary
  • Netherlands
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01460056 on ClinicalTrials.gov