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

This study has suspended participant recruitment.
(Suspended to conduct interval analysis.)
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.
ClinicalTrials.gov Identifier:
NCT01312675
First received: March 8, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Severe Sepsis
Device: S.A.F.E.BT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by B. Braun Medical Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
S.A.F.E.BT plus Standard of Care therapy
Device: S.A.F.E.BT
Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
No Intervention: Group B
Standard of Care therapy alone

Detailed Description:

Is extracorporeal treatment effective in the treatment of sepsis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312675

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
B. Braun Medical Inc.
Investigators
Study Director: Robert Wilkins, MBChB FRCA BBraun Inc
  More Information

No publications provided

Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT01312675     History of Changes
Other Study ID Numbers: BA-I-H-0903
Study First Received: March 8, 2011
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by B. Braun Medical Inc.:
severe sepsis
mechanical ventilation

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014