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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Is extracorporeal treatment effective in the treatment of sepsis

Conditions

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Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

S.A.F.E.BT

Intervention Type DEVICE

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

Group B

Standard of Care therapy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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S.A.F.E.BT

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No