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

This study is currently recruiting participants.

Verified February 2013 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: February 7, 2013

Last verified: February 2013

History of Changes

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:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	March 2014 (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

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

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

Locations

United States, Kentucky
University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40536
Contact: Amanda Zachem, RN 859-323-6347 ext 246 awzach@uky.edu
Principal Investigator: Philip Chang, MD
United States, Maryland
University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jessica Warren, RN 410-328-3657 jwarren@stapa.umm.edu
Principal Investigator: Matthew Lissauer, MD

Sponsors and Collaborators

B. Braun Medical 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:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by B. Braun Medical Inc.:

severe sepsis
mechanical ventilation

Additional relevant MeSH terms:

Sepsis
Toxemia
Infection

Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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