Klinisk prövning på Septisk chock, Svaghet - Kliniska prövningsregister

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: OTHER
Tidsperspektiv: PROSPECTIVE

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
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. Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90. Tidsram: 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 Tidsram: 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 Tidsram: 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. Tidsram: 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. Tidsram: 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. Tidsram: 90 days after inclusion	Quality of life measured by the EQ5D score at D90 (in hospital or at home).	90 days after inclusion

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Hospitalier de Lens

Samarbetspartners

University Hospital, Lille

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 augusti 2023

Primärt slutförande (Beräknad)

18 september 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

26 juni 2023

Först inskickad som uppfyllde QC-kriterierna