Klinisk prøve på Septisk sjokk, Skrøpelighet - Klinisk prøveregister

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

Recent studies show the impact of frailty in a middle-aged or even young population of patients admitted to critical care in terms of mortality (13), and the persistent risk of impairment of physical and mental capacities after resuscitation (14). To date, few studies have looked at clinical frailty as a risk factor for mortality in a middle-aged or young population, more specifically those suffering from septic shock, which is already known to be a major factor in morbidity and mortality (15,16), with repercussions on long-term quality of life.

The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.

In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.

The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.

This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: MELANIE VERLAY
Telefonnummer: 03.21.69.10.28
E-post: mverlay@ch-lens.fr

Studer Kontakt Backup

Navn: Guillaume DEGOUY, Dr
Telefonnummer: 03.21.69.12.34
E-post: gdegouy@ch-lens.fr

Studiesteder

Frankrike
- - Boulogne-sur-Mer, Frankrike, 62321
    - Rekruttering
    - CH Boulogne sur Mer
    - Hovedetterforsker:
      
      Charles DETOLLENAERE, Dr
  - Béthune, Frankrike, 62408
    - Rekruttering
    - Ch Germon Et Gauthier
    - Hovedetterforsker:
      
      Ghada SBOUI, Dr
  - Dijon, Frankrike, 21079
    - Rekruttering
    - CHU de Dijon
    - Hovedetterforsker:
      
      Jean-Pierre QUENOT, Pr
  - Lens, Frankrike
    - Rekruttering
    - CH de Lens
    - Hovedetterforsker:
      
      Guillaume DEGOUY, Doctor
  - Lille, Frankrike, 59037
    - Rekruttering
    - CHU Lille
    - Hovedetterforsker:
      
      Alexandre GAUDET, Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All patients admitted to intensive care will be studied for this study. Patients meeting the inclusion criteria and with no non-inclusion criteria will be included in the study after obtaining the patient's or relative's, if applicable, non-objection.

Beskrivelse

Inclusion Criteria:

Patients aged ≥18 years and ≤ 65 years
Patient admitted to intensive care - resuscitation
Patient admitted for suspected or documented type 3 sepsis
Presence of vasopressor amines to maintain MAP > 65mmHg despite filling
Lactatemia ≥ 2 mmol/L on admission.

Exclusion Criteria:

Patient moribund on admission
Patients with severe pre-existing dementia and/or cognitive decline, suffering from severe neurodegenerative diseases that prevent the patient from living independently at baseline, including mental illness requiring institutionalisation, including acquired or congenital mental retardation, etc.
Pregnant women or women in labour
Patients under guardianship or curatorship
Patients deprived of their liberty
Patient and/or family unable to speak or understand French.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: OTHER
Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
To show that the frailty score on admission is a risk factor for mortality at D28, independent of known risk factors, in young patients admitted to intensive care (ICU) for sepsis or septic shock. Tidsramme: 28 days after inclusion	The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28	28 days after inclusion

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90. Tidsramme: 90 days after inclusion	Time from admission to death or last news, censored at D90	90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay Tidsramme: 90 days after inclusion	The time between admission to IS and live discharge from hospital, death is considered a concurrent risk, the data are censored at 90 days	90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and the number of days with recourse to invasive therapies Tidsramme: 90 days after inclusion	Number of days with mechanical ventilation, with amines, with recourse to extra-renal purification (EER) during the IS stay.	90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90. Tidsramme: 90 days after inclusion	Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.	90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and describe changes in frailty between ICU admission and D90 in patients alive at D90. Tidsramme: 90 days after inclusion	Change in frailty score defined by the CFS (continuous) between admission and D90 (in hospital or at home).	90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and describe quality of life at D90 in patients alive at D90. Tidsramme: 90 days after inclusion	Quality of life measured by the EQ5D score at D90 (in hospital or at home).	90 days after inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier de Lens

Samarbeidspartnere

University Hospital, Lille

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. august 2023

Primær fullføring (Antatt)

18. september 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

26. juni 2023

Først innsendt som oppfylte QC-kriteriene