e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01460056
• Date of registration: 24/10/2011
• Prospective Registration: Yes
• Primary sponsor: Baxter Healthcare Corporation
• Public title: e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study e-STEPS
• Scientific title: e-STEPS: Endotoxin-Associated Sterile Peritonitis Observational Study
• Date of first enrolment: December 2011
• Target sample size: 127
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01460056
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Germany, Hungary, Netherlands, Portugal, United Kingdom

Contacts

• Name: Cory Sise, MD
• Affiliation: Baxter Healthcare Corporation

Key inclusion & exclusion criteria

1. 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).

2. 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).

3. 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Endotoxin-associated Sterile Peritonitis

Primary Outcome(s)

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.]

Secondary ID(s)

M-11378-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors