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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312675
Recruitment Status : Terminated (Study stopped for operational futility. Due to very small numbers of subjects, insufficient data was available for results to provide meaningful conclusions.)
First Posted : March 11, 2011
Last Update Posted : February 9, 2018
Information provided by (Responsible Party):
B. Braun Medical Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Severe Sepsis Device: S.A.F.E.BT Not Applicable

Detailed Description:
Is extracorporeal treatment effective in the treatment of sepsis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Baseline through Day 8 ]
    The primary outcome measure is the average of all changes in daily Sequential Organ Failure Assessment (SOFA) scores from baseline through Day 8.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312675

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.
Study Director: Robert Wilkins, MBChB FRCA BBraun Inc

Responsible Party: B. Braun Medical Inc. Identifier: NCT01312675     History of Changes
Other Study ID Numbers: BA-I-H-0903
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes