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

Severe Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01312675
• Other study ID #: BA-I-H-0903
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2018
• Source: B. Braun Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Is extracorporeal treatment effective in the treatment of sepsis

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

Device:
• S.A.F.E.BT
Five (5) S.A.F.E.BT treatments within a 7 day treatment period.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Day 8