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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.
 
ClinicalTrials.gov 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
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.

Study Description
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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 Design
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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

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) [ Time Frame: Baseline through Day 8 ]

    The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8.

    The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function).

    Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01312675


Locations
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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
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Study Director: Robert Wilkins, MBChB FRCA BBraun Inc
More Information
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Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT01312675    
Other Study ID Numbers: BA-I-H-0903
First Posted: March 11, 2011    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: September 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:
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Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes