Status:
COMPLETED
e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Endotoxin-associated Sterile Peritonitis
Eligibility:
All Genders
18+ years
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 endo...
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...
Eligibility Criteria
Inclusion
- Endotoxin-associated peritonitis (e-SP) subgroup:
- 1.
- 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.
- 2.
Exclusion
- 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
- 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. 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
- 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.
- 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).
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01460056
Start Date
December 1 2011
End Date
December 1 2012
Last Update
February 1 2013
Active Locations (12)
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1
Dialysepraxis Dessau
Dessau, Germany, 06847
2
Dialysezentrum Würzburg
Würzburg, Germany, 97072
3
Dialysezentrum Zwickau
Zwickau, Germany, 08060
4
B.Braun Avitum Zrt. 11 . sz. Dialízisközpont
Győr, Hungary, 9023