Severe SepsisSAFEbtNCT01312675

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

A study testing S.A.F.E.BT in people with Severe Sepsis, run by B. Braun Medical Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Sepsis
What is being tested?: S.A.F.E.BT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: Apr 2011to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Chronic cardiovascular disease precluding extracorporeal treatment
Human immunodeficiency virus complicated by AIDS defining illness
Evidence of active bleeding - uncontrolled hemorrhage

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Kentucky
Lexington, Kentucky, 40536

Other trials in United States

About this study

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

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.

Read the detailed description

Is extracorporeal treatment effective in the treatment of sepsis

Conditions: Severe Sepsis
Being tested: S.A.F.E.BT
Keywords: severe sepsis, mechanical ventilation
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01312675
Study group	Role	What they receive
Group A	Experimental	S.A.F.E.BT plus Standard of Care therapy Receives: Device: S.A.F.E.BT
Group B	No intervention	Standard of Care therapy alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline through Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jun 2015

First posted11 Mar 2011 (estimated)
Study startApr 2011
Primary completionMar 2015
Study completionJun 2015

Why it stopped: Study stopped for operational futility. Due to very small numbers of subjects, insufficient data was available for results to provide meaningful conclusions.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe SepsisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01312675
Sponsor's protocol ID: BA-I-H-0903
Acronym: SAFEbt
Status last verified: Sep 2018
First submitted: 8 Mar 2011
Last updated: 12 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01312675
Acronym / sponsor ID: SAFEbt / BA-I-H-0903
Conditions: Severe Sepsis
Keywords: severe sepsis, mechanical ventilation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped for operational futility. Due to very small numbers of subjects, insufficient data was available for results to provide meaningful conclusions.
Enrolment: 16 participants (actual)
Lead sponsor: B. Braun Medical Inc.Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Mar 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Mar 2011 (estimated)
Results: Posted 12 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: S.A.F.E.BTS.A.F.E.BT plus Standard of Care therapy
Group B	No intervention	–Standard of Care therapy alone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S.A.F.E.BTFive (5) S.A.F.E.BT treatments within a 7 day treatment period.	Device	Group A

Primary outcome

Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Time frame: Baseline through Day 8
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.

Results and safety

Results posted to the registry on 12 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	9	9
Group B	7	7

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

Time frame: Baseline through Day 8. Mean (Standard Deviation). Unit: scores on a scale

Measure	Group A n = 9	Group B n = 7
Screening	7.4 (2.70)	11.9 (3.24)
Day 1 / Baseline	6.9 (2.57)	11.9 (2.41)
Day 2	6.9 (2.09)	11.4 (3.10)
Day 3	6.1 (2.10)	10.4 (3.41)
Day 4	6.6 (2.83)	9.0 (3.61)
Day 5	6.9 (2.97)	7.0 (4.08)
Day 6	5.6 (3.55)	7.1 (2.85)
Day 7	5.1 (3.93)	8.1 (2.91)

Population analysed: Intent to Treat (ITT)

Adverse events

Time frame: 28 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	2 of 9 (22.2%)	9 of 9 (100%)	1 of 9
Group B	5 of 7 (71.4%)	7 of 7 (100%)	1 of 7

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Wilkins, MBChB FRCA study director

BBraun Inc

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing S.A.F.E.BT in people with Severe Sepsis, run by B. Braun Medical Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) (time frame: Baseline through Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01312675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.