Evaluation of the Performance of Sepsis Predictive Scores on the Elderly Population in the Emergency Department.

NCT04721275 | Unknown

• 1 other identifier: 2020_118
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Intra-hospital mortality at 28 days

  Intra-hospital mortality at 28 days

  28 days

Secondary Outcomes (4)

• Admission to intensive care unit

  28 days

• Length of hospital stay

  Up to 90 days

• Length of stay in the emergency room

  Up to 72 hours

• Door-to-antibiotic time

  Up to 72 hours

Study Arms (2)

Sepsis on the elderly population in ED

The elderly population is defined as patients over 65 years old of age.

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.

Other: measurement of pronostic sepsis scores

Interventions

measurement of pronostic sepsis scores OTHER

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).

Sepsis on the elderly population in ED; Sepsis on the non-elderly population in ED

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Adult presenting to the emergency department with suspected infection diagnosed by the emergency physician

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Centre Hospitalier Universitaire de Tours

Tours, 37000, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 26903338 RESULT

• Freund 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.

  PMID: 28114554 RESULT

• Singler 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.

  PMID: 24038772 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Geoffroy Rousseau, MD

CONTACT

+33247478109; geoffroy.rousseau@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ROUSSEAU Geoffroy, M.D.

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 22, 2021
• Study Start: January 18, 2021
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

FR (1)