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

NCT01312675 | Terminated Results DMC

• 1 other identifier: BA-I-H-0903
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Severe Sepsis

Keywords

severe sepsis; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: S.A.F.E.BT

Group B

NO INTERVENTION

Standard of Care therapy alone

Interventions

S.A.F.E.BT DEVICE

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

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Sepsis
• Mechanical ventilation due to acute pulmonary dysfunction
• One additional (second) acute sepsis-related organ dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study did not reach the target number of participants needed to achieve target power and statistically reliable results leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Dr. Diana Velencia, Associate Director of Clinical Affairs
• Organization: B. Braun Medical Inc.

diana.valencia@bbraunusa.com

610-596-2875

Study Officials

• Robert Wilkins, MBChB FRCA

  BBraun Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 11, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)