SepsisBIPSNCT02707718
Biomarkers for the Early Identification of Sepsis in the Emergency Department
An observational study of Sepsis, run by Pitié-Salpêtrière Hospital at 2 sites in France.
Trial summary
Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- blood sampling
- How many people
- 320 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2016to 3 Mar 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients attending the ED and suspected to have sepsis
Who may be able to join
- patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam
Who cannot join
- patient minor under 18-year
- pregnancy
- anticipated no follow-up possible (homeless...)
- Refusal to participate
- patient under curators, prisoner
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié Salpêtrière
Paris, 75013
Institut Pasteur
Paris, 75015
About this study
Official title: Early Biomarkers of Sepsis Identification in the Emergency Department
Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.
Read the detailed description
The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis.
Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection.
Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.
- Conditions
- Sepsis
- Being tested
- blood sampling
- Keywords
- sepsis, biomarker, prognostic, emergency department, diagnosis
- Medical subject headings
- Sepsis, Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis diagnosis
Among the patients included in the study with a sepsis suspicion, the primary outcome measure will be a final diagnosis of sepsis adjudicated on the medical file and 30-day follow-up, by an expert panel blind for the biomarkers studied
Measured: 30-day after inclusion
Secondary outcomes (1)
severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up
Among the patients included in the study with a sepsis suspicion, a diagnosis of severe sepsis and/or septic shock will be adjudicated on the medical file and 30-day follow-up by an expert panel blind for the biomarkers studied. ICu admission and death will be recorded by the medical file and 30-day phone interview.
Measured: 30-day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pitié-Salpêtrière Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Bio-Rad Laboratories
- Responsible party
- Principal investigator, Hausfater Pierre, Pitié-Salpêtrière Hospital
- Investigators
- pierre Hausfater, Md PhD, Principal investigator, ARCEAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707718
- Sponsor's protocol ID
- BIPS study
- Acronym
- BIPS
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2016
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers of Sepsis Identification in the Emergency Department
- ClinicalTrials.gov ID
- NCT02707718
- Acronym / sponsor ID
- BIPS / BIPS study
- Conditions
- Sepsis
- Keywords
- sepsis, biomarker, prognostic, emergency department, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Pitié-Salpêtrière HospitalUniversity, hospital or other
- Collaborators
- Institut Pasteur, Bio-Rad Laboratories
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 14 Mar 2016 (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.
Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.
Detailed description
The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis.
Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection.
Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients attending the ED and suspected to have sepsis
Key inclusion criteria (1 listed)
- patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam
Key exclusion criteria (5 listed)
- patient minor under 18-year
- pregnancy
- anticipated no follow-up possible (homeless...)
- Refusal to participate
- patient under curators, prisoner
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 samplingduring the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement | Biological | – |
Primary outcome
sepsis diagnosis
Time frame: 30-day after inclusion
Among the patients included in the study with a sepsis suspicion, the primary outcome measure will be a final diagnosis of sepsis adjudicated on the medical file and 30-day follow-up, by an expert panel blind for the biomarkers studied
1 secondary outcome
severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up
Time frame: 30-day after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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.
pierre Hausfater, Md PhD principal investigator
ARCEAR
2 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 Pitié-Salpêtrière Hospital at 2 sites in France.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sepsis diagnosis (time frame: 30-day after inclusion). It is what the study was designed to measure, not a finding.
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 17 Apr 2018.