SepsisMINDSETNCT00472628
Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)
An observational study of Sepsis, run by Abbott RDx Cardiometabolic at 24 sites in United States.
Trial summary
The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood samples collected
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 24 sitesUnited States
- Study dates
- May 2007to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Male or female 18 years of age or older
- Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation
- Exhibiting two or more of any diagnostic criteria for sepsis
- Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28
Who cannot join
- Age < 18 years
- Participation in any interventional clinical study within the previous 30 days
- Status-post cardiac arrest (within the past month)
- Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status
- Prisoners or other institutionalized or vulnerable individuals
- Already a hospital in-patient
- Unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for Day 3, 14, and 28 status assessments if discharged
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Emory University
Atlanta, Georgia
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Cooper Health
Camden, New Jersey
Northwestern University
Chicago, Illinois
Cleveland Clinic
Cleveland, Ohio
Denver Health
Denver, Colorado
Henry Ford Health System
Detroit, Michigan
Wayne State - Detroit Receiving Hospital
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina
LA County/ USC
Los Angeles, California
North Shore University Hospital
Manhasset, New York
Albert Einstein Medical Center
Philadelphia, Pennsylvania
Temple University
Philadelphia, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania
Brown University
Providence, Rhode Island
Virginia Commonwealth University Medical Center
Richmond, Virginia
Bay State Medical Center
Springfield, Massachusetts
Staten Island University Hospital
Staten Island, New York
SUNY Stony Brook
Stony Brook, New York
Olive View Medical Center - UCLA
Sylmar, California
George Washington University
Washington D.C., District of Columbia
Wake Forest University
Winston-Salem, North Carolina
About this study
Official title: Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department
The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.
Read the detailed description
This is a multi-center, prospective specimen procurement study. The samples will be used for future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the Emergency Department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the ICU. Approximately 700 patients presenting to the Emergency Department (ED) with at least two of the symptoms or signs of sepsis will be enrolled in this study.
The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical status.
Patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points).
Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess the duration of hospital stay and mortality through Days 14 and 28.
- Conditions
- Sepsis
- Being tested
- Blood samples collected
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collectedProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMay 2007
- Study completionAug 2007
Why it stopped: Change in company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Investigators
- Emanuel Rivers, MD, MPH, Principal investigator, Henry Ford HospitalMitchell Levy, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472628
- Sponsor's protocol ID
- BSTE-0501 - CLOSED
- Other IDs
- Study Closed 9/13/07
- Acronym
- MINDSET
- Status last verified
- Jul 2015
- First submitted
- 10 May 2007
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department
- ClinicalTrials.gov ID
- NCT00472628
- Acronym / sponsor ID
- MINDSET / BSTE-0501 - CLOSED
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change in company strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Not posted in the source record
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 the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.
Detailed description
This is a multi-center, prospective specimen procurement study. The samples will be used for future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the Emergency Department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the ICU. Approximately 700 patients presenting to the Emergency Department (ED) with at least two of the symptoms or signs of sepsis will be enrolled in this study.
The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical status.
Patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points).
Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess the duration of hospital stay and mortality through Days 14 and 28.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 years of age or older
- Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation
- Exhibiting two or more of any diagnostic criteria for sepsis
- Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28
Key exclusion criteria (7 listed)
- Age < 18 years
- Participation in any interventional clinical study within the previous 30 days
- Status-post cardiac arrest (within the past month)
- Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status
- Prisoners or other institutionalized or vulnerable individuals
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 |
|---|---|---|
| Blood samples collected | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Emanuel Rivers, MD, MPH principal investigator
Henry Ford Hospital
Mitchell Levy, MD principal investigator
Rhode Island Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Abbott RDx Cardiometabolic at 24 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 21 Jul 2015.