SepsisNCT03237403
Hospital Orientation Since SAMU Regulation Centre Call
An observational study of Sepsis, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- observational study
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Jan 2019
- 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
Study population: All subjects calling the SAMU regulation centre call with a clinical suspected sepsis history
Who may be able to join
- adults (age>18years)
- patients with suspected sepsis state at the regulation SAMU centre call
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP Necker Enfants Malades
Paris, 75015
Romain Jouffroy, MD, +3314495989, romain.jouffroy@aphp.fr
Benoit Vivien, MD, PhD, +33144492424, benoit.vivien@aphp.fr
About this study
Official title: Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State
Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit
Read the detailed description
Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation
- Conditions
- Sepsis
- Being tested
- observational study
- Keywords
- Sepsis, Adults, Pre hospital settings, Triage, Hospital orientation, Outcome
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Admission Service
Emergency department or intensive care unit
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Jouffroy, Hôpital Necker-Enfants Malades
- Investigators
- Romain Jouffroy, MD, Principal investigator, APHP Necker Enfants Malades SAMU 75
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237403
- Sponsor's protocol ID
- 2017-A02335-48
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan is planned
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State
- ClinicalTrials.gov ID
- NCT03237403
- Acronym / sponsor ID
- 2017-A02335-48
- Conditions
- Sepsis
- Keywords
- Sepsis, Adults, Pre hospital settings, Triage, Hospital orientation, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
Specify the association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call in patients with suspected sepsis and their hospital orientation: emergency department or intensive care unit
Detailed description
Anonymous, descriptive, longitudinal, resting study searching an association between clinical criteria transmitted by non-medical emergency services to the regulation of the SAMU centre call for patients with suspected sepsis and their subsequent hospital orientation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects calling the SAMU regulation centre call with a clinical suspected sepsis history
Key inclusion criteria (2 listed)
- adults (age>18years)
- patients with suspected sepsis state at the regulation SAMU centre call
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| observational studyobservational study between clinical criteria collected at SAMU regulation centre call and hospital orientation | Other | – |
Primary outcome
Hospital Admission Service
Time frame: 1 day
Emergency department or intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No. No IPD sharing plan is planned
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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.
Romain Jouffroy, MD principal investigator
APHP Necker Enfants Malades SAMU 75
1 site 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 Hôpital Necker-Enfants Malades at 1 site 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romain Jouffroy, MD (+3314495989, romain.jouffroy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Admission Service (time frame: 1 day). 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 3 Aug 2017.