- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07707765
The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Daniel Leshin Carmel, MD
- Telefonnummer: +972525253037
- E-post: danielles@bmc.gov.il
Studera Kontakt Backup
- Namn: Pnina Nir
- E-post: pninan@bmc.gov.il
Studieorter
-
-
-
Ashkelon, Israel
- Rekrytering
- Barzilai Medical Center
-
Kontakt:
- Daniel Leshin-Carmel, MD
- Telefonnummer: +972525253037
- E-post: danielles@bmc.gov.il
-
Kontakt:
- pnina nir, study coordinator
- E-post: pninan@bmc.gov.il
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Early psychiatric intervention
Interventional arm.
Early intervention after discharge from ICU.
|
Psychiatric interview for 45 minutes
|
|
Inget ingripande: No intervention
Observational arm.
No intervention after discharge from ICU.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PTSD risk according to PCL-5
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression risk
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Daniel Leshin Carmel, MD, Barzilai Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0041-26-BRZ
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .