SepsisNCT04721275
Evaluation of the Performance of Sepsis Predictive Scores on the Elderly Population in the Emergency Department.
An observational study of Sepsis, run by University Hospital, Tours at 1 site in France.
Trial summary
The main objective of the research is to evaluate the prognostic performance of qSOFA, NEWS and MEDS scores in patients over 65 years of age presenting to the emergency department with a diagnosis of infection made by the emergency physician in charge. The main judgment criterion is intra-hospital mortality. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- measurement of pronostic sepsis scores
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 1 Aug 2021
- 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
- Adult, Older adult
Study population: The patients recruited will be those who's the emergency doctor in charge suspects an infection, either through clinical examination or complementary examinations (radiological, microbiological). The diagnosis of bacterial infection will be re-evaluated remotely by 2 experts once the follow-up phase is completed. In case of discrepancies, a consensus will be reached between the 2 experts. Patients with no confirmed infection will be excluded from the study. We also exclude pregnant women, minors, patients under legal protection, or patients refusing to participate, prisoners and patients with localized infections without general repercussions (abscess, cystitis, angina). For each patient included, the reception and orientation nurse assisted by the emergency doctor will have to fill in the parameters needed to calculate qSOFA score, the NEWS score and the MEDS score on admission.
Who may be able to join
- Adult presenting to the emergency department with suspected infection diagnosed by the emergency physician
Who cannot join
- Minors, vulnerable person (legal protection)
- Pregnancy
- Prisoner
- Infection not confirmed after review of the medical record by two experts
- Localized infection without general repercussions: abscess, angina, otitis, cystitis
- Patient's opposition to participate to the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Tours
Tours, 37000
Geoffroy Rousseau, MD, +33247478109, geoffroy.rousseau@chu-tours.fr
About this study
The main objective of the research is to evaluate the prognostic performance of qSOFA, NEWS and MEDS scores in patients over 65 years of age presenting to the emergency department with a diagnosis of infection made by the emergency physician in charge.
The main judgment criterion is intra-hospital mortality. Secondary criteria for judgement are admission to intensive care or intensive care (continuous monitoring unit), length of hospital stay, length of stay in the emergency room, length of time before antibiotic therapy is administered. A comparison of score performance will be carried out between the population aged over 65 years old and the rest of the population.
Read the detailed description
The main objective of the research is to evaluate the prognostic performance of qSOFA, NEWS and MEDS scores in patients over 65 years of age presenting to the emergency department with a diagnosis of infection made by the emergency physician in charge.
The main judgment criterion is intra-hospital mortality. Secondary criteria for judgement are admission to intensive care or intensive care (continuous monitoring unit), length of hospital stay, length of stay in the emergency room, door-to-antibiotic time. A comparison of score performance will be carried out between the population aged over 65 years old and the rest of the population.
- EXPECTED FALLOUT. Early recognition of patients with potentially severe sepsis and adaptation to monitoring appropriate to severity will enable patients to be identified and managed more quickly from the time of assessment by the emergency reception and referral nurse. In this way, these patients can be integrated into a dedicated line of care enabling early antibiotic therapy, vascular filling and support by vasopressor amines if necessary. Older people present a particularly fragile population with physiological peculiarities. It is necessary to validate these prognostic scores in this segment of the population.
- EXPERIMENTAL PLAN. 4.1 Design of the study. This study will be a monocentric, prospective, non-interventional study. The patients recruited will be those who's the emergency doctor in charge suspects an infection, either through clinical examination or complementary examinations (radiological, microbiological). The diagnosis of bacterial infection will be re-evaluated remotely by 2 experts once the follow-up phase is completed. In case of discrepancies, a consensus will be reached between the 2 experts. Patients with no confirmed infection will be excluded from the study. Investigators also exclude pregnant women, minors, patients under legal protection, or patients refusing to participate, prisoners and patients with localized infections without general repercussions (abscess, cystitis, angina). For each patient included, the reception and orientation nurse assisted by the emergency doctor will have to fill in the parameters needed to calculate qSOFA score, the NEWS score and the MEDS score on admission. The main judgment criterion is intra-hospital mortality at 28 days. Patients still hospitalized after D28 will be considered still alive. Secondary endpoints will be admission to intensive care (resuscitation/continuous monitoring unit) for more than 72 hours, length of hospital stay, length of stay in intensive care, door-to-antibiotic time and a composite endpoint of mortality or admission to intensive care for more than 72 hours. 4.2 Criteria for inclusion: Adult patient presenting to the adult emergency department with suspected infection by the reception and orientation nurse or diagnosed by the emergency physician. One subgroup is composed of patients aged 65 years and over, a second subgroup is composed of patients aged 18 to 64 years. 4.3 Exclusion criteria: Underage patients, vulnerable persons (legal protection) Pregnant women Prisoner Infection not confirmed after review of the files by the experts Localized infection without general repercussions: abscess, angina, cystitis. Patient's opposition to participating in the study Inclusion period: 6 months Follow-up period: 28 days Place of study: emergency department of the Tours CHRU (University Hospital Centre)
- BENEFIT/RISK The study provides a reminder to practitioners of the international recommendations for sepsis management based on the Surviving Sepsis Campaign. It can thus be expected to improve the time taken by patients to receive antibiotic therapy and potentially improve the triage of these patients. There is no risk expected by this study since there is no change in practices. The objective of this study is to evaluate prognostic performance of scores without intervention on patient management.
- STATISTICAL ANALYSES
Numerical variables will be expressed as average and 95% confidence interval, and categorical variables will be expressed as number and percentage. In the case of missing variables for scores, investigators assume that the values are within normal values. To achieve the performance of the qSOFA, NEWS and MEDS scores in predicting the main judgement criterion, investigators will calculate the diagnostic performance (sensitivity, specificity, positive and negative predictive values) for a qSOFA greater than or equal to 2, a NEWS ≥ 5 and a MEDS greater than or equal to 12. Investigators will construct a ROC curve and calculate an area under the curve for each score. The scores will be compared with each other in the population over 65 years old. Each score will also be compared between the population over 65 and the population 18-64.
A p value of less than 0.05 is considered significant. The analyses are performed using R software version 3.6.2.
- Conditions
- Sepsis
- Being tested
- measurement of pronostic sepsis scores
- 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 pronostic sepsis scoresOther
qSOFA, NEWS and MEDS sores are measured to each patient admitted in the emergency department with a suspicion of infection (excluding localized infection as abscess, angina, cystitis).
| Study group | Role | What they receive |
|---|---|---|
| Sepsis on the elderly population in ED | The elderly population is defined as patients over 65 years old of age. Receives: Other: measurement of pronostic sepsis scores | |
| Sepsis on the non-elderly population in ED | The non-elderly population is defined as patients aged of 18 to 64 years old. Receives: Other: measurement of pronostic sepsis scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-hospital mortality at 28 days
Intra-hospital mortality at 28 days
Measured: 28 days
Secondary outcomes (4)
Admission to intensive care unit
Admission to intensive care unit
Measured: 28 days
Length of hospital stay
In-hospital length of stay
Measured: Up to 90 days
Length of stay in the emergency room
Length of stay in the emergency room
Measured: Up to 72 hours
Door-to-antibiotic time
Door-to-antibiotic time defined as the time between the admission to the hospital and the first antibiotic administration
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start18 Jan 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEOFFROY ROUSSEAU, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721275
- Sponsor's protocol ID
- 2020_118
- Status last verified
- Apr 2021
- First submitted
- 16 Jan 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.
PubMed 28114554Singler K, Bertsch T, Heppner HJ, Kob R, Hammer K, Biber R, Sieber CC, Christ M. Diagnostic accuracy of three different methods of temperature measurement in acutely ill geriatric patients. Age Ageing. 2013 Nov;42(6):740-6. doi: 10.1093/ageing/aft121. Epub 2013 Sep 13.
PubMed 24038772
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Sepsis Predictive Scores on the Elderly Population in the Emergency Department.
- ClinicalTrials.gov ID
- NCT04721275
- Acronym / sponsor ID
- 2020_118
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
The main objective of the research is to evaluate the prognostic performance of qSOFA, NEWS and MEDS scores in patients over 65 years of age presenting to the emergency department with a diagnosis of infection made by the emergency physician in charge.
The main judgment criterion is intra-hospital mortality. Secondary criteria for judgement are admission to intensive care or intensive care (continuous monitoring unit), length of hospital stay, length of stay in the emergency room, length of time before antibiotic therapy is administered. A comparison of score performance will be carried out between the population aged over 65 years old and the rest of the population.
Detailed description
The main objective of the research is to evaluate the prognostic performance of qSOFA, NEWS and MEDS scores in patients over 65 years of age presenting to the emergency department with a diagnosis of infection made by the emergency physician in charge.
The main judgment criterion is intra-hospital mortality. Secondary criteria for judgement are admission to intensive care or intensive care (continuous monitoring unit), length of hospital stay, length of stay in the emergency room, door-to-antibiotic time. A comparison of score performance will be carried out between the population aged over 65 years old and the rest of the population.
- EXPECTED FALLOUT. Early recognition of patients with potentially severe sepsis and adaptation to monitoring appropriate to severity will enable patients to be identified and managed more quickly from the time of assessment by the emergency reception and referral nurse. In this way, these patients can be integrated into a dedicated line of care enabling early antibiotic therapy, vascular filling and support by vasopressor amines if necessary. Older people present a particularly fragile population with physiological peculiarities. It is necessary to validate these prognostic scores in this segment of the population.
- EXPERIMENTAL PLAN. 4.1 Design of the study. This study will be a monocentric, prospective, non-interventional study. The patients recruited will be those who's the emergency doctor in charge suspects an infection, either through clinical examination or complementary examinations (radiological, microbiological). The diagnosis of bacterial infection will be re-evaluated remotely by 2 experts once the follow-up phase is completed. In case of discrepancies, a consensus will be reached between the 2 experts. Patients with no confirmed infection will be excluded from the study. Investigators also exclude pregnant women, minors, patients under legal protection, or patients refusing to participate, prisoners and patients with localized infections without general repercussions (abscess, cystitis, angina). For each patient included, the reception and orientation nurse assisted by the emergency doctor will have to fill in the parameters needed to calculate qSOFA score, the NEWS score and the MEDS score on admission. The main judgment criterion is intra-hospital mortality at 28 days. Patients still hospitalized after D28 will be considered still alive. Secondary endpoints will be admission to intensive care (resuscitation/continuous monitoring unit) for more than 72 hours, length of hospital stay, length of stay in intensive care, door-to-antibiotic time and a composite endpoint of mortality or admission to intensive care for more than 72 hours. 4.2 Criteria for inclusion: Adult patient presenting to the adult emergency department with suspected infection by the reception and orientation nurse or diagnosed by the emergency physician. One subgroup is composed of patients aged 65 years and over, a second subgroup is composed of patients aged 18 to 64 years. 4.3 Exclusion criteria: Underage patients, vulnerable persons (legal protection) Pregnant women Prisoner Infection not confirmed after review of the files by the experts Localized infection without general repercussions: abscess, angina, cystitis. Patient's opposition to participating in the study Inclusion period: 6 months Follow-up period: 28 days Place of study: emergency department of the Tours CHRU (University Hospital Centre)
- BENEFIT/RISK The study provides a reminder to practitioners of the international recommendations for sepsis management based on the Surviving Sepsis Campaign. It can thus be expected to improve the time taken by patients to receive antibiotic therapy and potentially improve the triage of these patients. There is no risk expected by this study since there is no change in practices. The objective of this study is to evaluate prognostic performance of scores without intervention on patient management.
- STATISTICAL ANALYSES
Numerical variables will be expressed as average and 95% confidence interval, and categorical variables will be expressed as number and percentage. In the case of missing variables for scores, investigators assume that the values are within normal values. To achieve the performance of the qSOFA, NEWS and MEDS scores in predicting the main judgement criterion, investigators will calculate the diagnostic performance (sensitivity, specificity, positive and negative predictive values) for a qSOFA greater than or equal to 2, a NEWS ≥ 5 and a MEDS greater than or equal to 12. Investigators will construct a ROC curve and calculate an area under the curve for each score. The scores will be compared with each other in the population over 65 years old. Each score will also be compared between the population over 65 and the population 18-64.
A p value of less than 0.05 is considered significant. The analyses are performed using R software version 3.6.2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis on the elderly population in ED | – | Other: measurement of pronostic sepsis scoresThe elderly population is defined as patients over 65 years old of age. |
| Sepsis on the non-elderly population in ED | – | Other: measurement of pronostic sepsis scoresThe non-elderly population is defined as patients aged of 18 to 64 years old. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients recruited will be those who's the emergency doctor in charge suspects an infection, either through clinical examination or complementary examinations (radiological, microbiological). The diagnosis of bacterial infection will be re-evaluated remotely by 2 experts once the follow-up phase is completed. In case of discrepancies, a consensus will be reached between the 2 experts. Patients with no confirmed infection will be excluded from the study. We also exclude pregnant women, minors, patients under legal protection, or patients refusing to participate, prisoners and patients with localized infections without general repercussions (abscess, cystitis, angina). For each patient included, the reception and orientation nurse assisted by the emergency doctor will have to fill in the parameters needed to calculate qSOFA score, the NEWS score and the MEDS score on admission.
Key inclusion criteria (1 listed)
- Adult presenting to the emergency department with suspected infection diagnosed by the emergency physician
Key exclusion criteria (6 listed)
- Minors, vulnerable person (legal protection)
- Pregnancy
- Prisoner
- Infection not confirmed after review of the medical record by two experts
- Localized infection without general repercussions: abscess, angina, otitis, cystitis
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 pronostic sepsis scoresqSOFA, NEWS and MEDS sores are measured to each patient admitted in the emergency department with a suspicion of infection (excluding localized infection as abscess, angina, cystitis). | Other | Sepsis on the elderly population in ED, Sepsis on the non-elderly population in ED |
Primary outcome
Intra-hospital mortality at 28 days
Time frame: 28 days
Intra-hospital mortality at 28 days
4 secondary outcomes
Admission to intensive care unit
Time frame: 28 days
Length of hospital stay
Time frame: Up to 90 days
Length of stay in the emergency room
Time frame: Up to 72 hours
Door-to-antibiotic time
Time frame: Up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Results publication: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Results publication: PubMed 28114554Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.
- Results publication: PubMed 24038772Singler K, Bertsch T, Heppner HJ, Kob R, Hammer K, Biber R, Sieber CC, Christ M. Diagnostic accuracy of three different methods of temperature measurement in acutely ill geriatric patients. Age Ageing. 2013 Nov;42(6):740-6. doi: 10.1093/ageing/aft121. Epub 2013 Sep 13.
- Individual participant dataSharing planned: Undecided
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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.
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 University Hospital, Tours 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 1 inclusion and 6 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 27 Apr 2021. 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 Geoffroy Rousseau, MD (+33247478109, geoffroy.rousseau@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-hospital mortality at 28 days (time frame: 28 days). 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 NCT04721275, which also lists 3 linked publications.
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 27 Apr 2021.