- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07707765
The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
In recent years, there has been a significant increase in the survival rate of patients hospitalized in intensive care, due in part to improved capabilities in diagnosing and treating severe infections and sepsis, the use of broad-spectrum antibiotics, and the development of advanced life-support technologies. However, alongside this rise in survival, it has become evident that many patients continue to suffer from long-term complications following their discharge from intensive care. This phenomenon is described in the literature as Post-Intensive Care Syndrome (PICS) and encompasses physical, cognitive, and psychological impairments that develop or persist after an intensive care stay.
Among the prominent psychological consequences following an intensive care unit (ICU) stay is post-traumatic stress disorder (PTSD), alongside symptoms of anxiety and depression. Various studies indicate that a significant proportion (9-27%) of ICU survivors develop post-traumatic symptoms; while these may appear during the hospital stay itself, they sometimes develop or worsen after discharge. Potential risk factors for the development of these symptoms include traumatic experiences during the hospital stay, delirium, prolonged mechanical ventilation, exposure to certain medications, and the severity of the underlying illness.
Patients hospitalized in the ICU due to sepsis constitute a particularly high-risk population for developing these symptoms, given the severity of the illness, the duration of the hospital stay, and exposure to numerous invasive procedures. Beyond the psychological impact, post-traumatic symptoms can significantly affect patients' quality of life, daily functioning, and recovery process following hospital discharge.
Despite the prevalence of this phenomenon, most medical centers currently lack a structured model for screening and early intervention among patients discharged from the ICU. Most research in this field focuses on identifying the phenomenon or describing its risk factors, whereas data regarding the efficacy of early interventions to prevent PTSD following ICU hospitalization remain limited.
In light of this, there is a need to evaluate the feasibility of an early intervention model for patients discharged from the intensive care unit following hospitalization for sepsis. Such an intervention could help identify at-risk patients early, reduce the severity of psychological symptoms, and improve their quality of life after hospital discharge.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Daniel Leshin Carmel, MD
- Telefonnummer: +972525253037
- E-post: danielles@bmc.gov.il
Studer Kontakt Backup
- Navn: Pnina Nir
- E-post: pninan@bmc.gov.il
Studiesteder
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Ashkelon, Israel
- Rekruttering
- Barzilai Medical Center
-
Ta kontakt med:
- Daniel Leshin-Carmel, MD
- Telefonnummer: +972525253037
- E-post: danielles@bmc.gov.il
-
Ta kontakt med:
- pnina nir, study coordinator
- E-post: pninan@bmc.gov.il
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Discharged from ICU due to sepsis
- Age over 18 years old
Exclusion Criteria:
- Age under 18 years old
- Lack of consent
- Dementia/ mental retardation or any other condition due to which the patient cannot fill the questionnaires or participate in the psychiatric interview.
- A cute psychosis or other psychiatric condition nesiccating psychiatric treatment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Early psychiatric intervention
Interventional arm.
Early intervention after discharge from ICU.
|
Psychiatric interview for 45 minutes
|
|
Ingen inngripen: No intervention
Observational arm.
No intervention after discharge from ICU.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PTSD risk according to PCL-5
Tidsramme: 30 days
|
Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5).
The PCL-5 is widely used in clinical and research settings to screen for PTSD, assess symptom severity, and monitor treatment progress over time.
Total scores can range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
In addition to a raw score being presented, a mean score is also computed, which is the subscale score divided by the number of items within that subscale.
The average score can help determine elevated symptom clusters when comparing each of the four subscales.
These scores range between 0 to 4, where higher scores represent higher severity.
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression risk
Tidsramme: 30 days
|
Patient Health Questionnaire-9 is a validated, 9-question tool to assess for the degree of depression present in an individual.
The total score ranges from 0 to 27.
The higher the score is the more severe the depression is.
|
30 days
|
|
General well being
Tidsramme: 30 days
|
This questionnaire is designed to measure general well-being, including negative well-being, energy and positive well-being.
The Well-Being Questionnaire (W-BQ) was first developed in the early 1980s as a 22-item measure.
The range is from 0 to 110, the higher the score the better is the general well being.
|
30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Daniel Leshin Carmel, MD, Barzilai Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0041-26-BRZ
Plan for individuelle deltakerdata (IPD)
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