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

Primary Purpose

Severe Sepsis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
S.A.F.E.BT
Sponsored by
B. Braun Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring severe sepsis, mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky
  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

S.A.F.E.BT plus Standard of Care therapy

Standard of Care therapy alone

Outcomes

Primary Outcome Measures

Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2011
Last Updated
September 14, 2018
Sponsor
B. Braun Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01312675
Brief Title
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
Acronym
SAFEbt
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Study stopped for operational futility. Due to very small numbers of subjects, insufficient data was available for results to provide meaningful conclusions.
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Medical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
severe sepsis, mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
S.A.F.E.BT plus Standard of Care therapy
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Standard of Care therapy alone
Intervention Type
Device
Intervention Name(s)
S.A.F.E.BT
Intervention Description
Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Description
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.
Time Frame
Baseline through Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wilkins, MBChB FRCA
Organizational Affiliation
BBraun Inc
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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