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

B. Braun Medical Inc.16 enrolled

Overview

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.

Is extracorporeal treatment effective in the treatment of sepsis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Sepsis

Interventions

S.A.F.E.BTDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Kentucky

Lexington, Kentucky, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline through Day 8

Data from ClinicalTrials.gov

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