S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT (SAFEbt)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by B. Braun Medical Inc.
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.
ClinicalTrials.gov Identifier:
NCT01312675
First received: March 8, 2011
Last updated: March 19, 2014
Last verified: March 2014

March 8, 2011
March 19, 2014
April 2011
March 2015   (final data collection date for primary outcome measure)
Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Baseline through Day 8 ] [ Designated as safety issue: No ]
The primary outcome measure is the average of all changes in daily Sequential Organ Failure Assessment (SOFA) scores from baseline through Day 8.
Same as current
Complete list of historical versions of study NCT01312675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
Randomized, Multi-Centre, Controlled Clinical Study on Effect of the Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) Therapy on Disease Severity and Inflammation in Mechanically-Ventilated Subjects Due to Severe Sepsis

The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.

Is extracorporeal treatment effective in the treatment of sepsis

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Sepsis
Device: S.A.F.E.BT
Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
  • Experimental: Group A
    S.A.F.E.BT plus Standard of Care therapy
    Intervention: Device: S.A.F.E.BT
  • No Intervention: Group B
    Standard of Care therapy alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Clinical diagnosis of Sepsis
  • Mechanical ventilation due to acute pulmonary dysfunction
  • One additional (second) acute sepsis-related organ dysfunction

Exclusion Criteria

  • Pregnant women and nursing mothers
  • Conditions or medications associated with an increased risk of bleeding/complications from anticoagulation
  • Previous episode of sepsis during this hospitalization
  • PaO2/FiO2 ratio < 300
  • Severe granulocytopenia (leukocytes <500 / μl)
  • Acute hepatic diseases or severe liver failure or cirrhosis
  • Chronic cardiovascular disease precluding extracorporeal treatment
  • Human immunodeficiency virus complicated by AIDS defining illness
  • Evidence of active bleeding - uncontrolled hemorrhage
Both
18 Years and older
No
Contact: Patricia Beach, MBA 610-596-2835 patt.beach@bbraun.com
United States
 
NCT01312675
BA-I-H-0903
Yes
B. Braun Medical Inc.
B. Braun Medical Inc.
Not Provided
Study Director: Robert Wilkins, MBChB FRCA BBraun Inc
B. Braun Medical Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP