SepsisDELTASCREENNCT02926664
Delta qSOFA for Risk Stratification in Emergency Infected Patients
An observational study of Sepsis, run by Societe Française de Medecine d'urgence at 10 sites in 3 countries.
Trial summary
The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- measurement of qSOFA
- How many people
- 512 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Oct 2016to 1 May 2017
- 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: Adult patients in the ED who presents with suspicion of infection AND a qSOFA of at least 2.
Who may be able to join
- suspicion of infection by the emergency physicians
- at least two of the following criteria : respiratory rate <= 22, systolic blood pressure <= 100 mmHg and altered mental status
Who cannot join
- Infection ruled out by the expert after chart review
- patient who refuse to participate
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
France8 sites
CHU Nimes
Nîmes
Cochin
Paris
Hopital Europeen Georges Pompidou
Paris
Hopital Pitié-Salpêtrière
Paris
Hopital Tenon
Paris
Lariboisière
Paris
Saint Antoine
Paris
CHU Strasbourg
Strasbourg
About this study
Official title: Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department
The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.
Read the detailed description
qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection.
However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value.
Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included.
After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours.
Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA >0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA > 0 and Delta qSOFA<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.
- Conditions
- Sepsis
- Being tested
- measurement of qSOFA
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of qSOFAOther
qSOFA will be measured at H0, H1 and H3
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 60 days
Secondary outcomes (2)
ICU admission more than 72 hours
Measured: 60 days
ICU admission
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Française de Medecine d'urgence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonathan Freund, Societe Française de Medecine d'urgence
- Investigators
- Yonathan Freund, Principal investigator, Emergency Department - hopital pitie salpetriere, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926664
- Sponsor's protocol ID
- DeltaSCREEN
- Acronym
- DELTASCREEN
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2016
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: data will be available upon request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department
- ClinicalTrials.gov ID
- NCT02926664
- Acronym / sponsor ID
- DELTASCREEN / DeltaSCREEN
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Societe Française de Medecine d'urgenceUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 6 Oct 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.
The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.
Detailed description
qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection.
However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value.
Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included.
After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours.
Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA >0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA > 0 and Delta qSOFA<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in the ED who presents with suspicion of infection AND a qSOFA of at least 2.
Key inclusion criteria (2 listed)
- suspicion of infection by the emergency physicians
- at least two of the following criteria : respiratory rate <= 22, systolic blood pressure <= 100 mmHg and altered mental status
Key exclusion criteria (2 listed)
- Infection ruled out by the expert after chart review
- patient who refuse to participate
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 |
|---|---|---|
| measurement of qSOFAqSOFA will be measured at H0, H1 and H3 | Other | – |
Primary outcome
In-hospital mortality
Time frame: 60 days
2 secondary outcomes
ICU admission more than 72 hours
Time frame: 60 days
ICU admission
Time frame: 60 days
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 24 Oct 2017.
- Individual participant dataSharing planned: Yes. data will be available upon request to the principal investigator
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.
Yonathan Freund principal investigator
Emergency Department - hopital pitie salpetriere, Paris, France
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Societe Française de Medecine d'urgence at 10 sites in 3 countries.
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 2 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium, Spain. 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?
In-hospital mortality (time frame: 60 days). 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 24 Oct 2017.