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- Essai clinique NCT07707765
The Effect of Early Intervention on the Incidence of Posttraumatic Stress Disorder After Intensive Care Hospitalization Due to Sepsis
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Daniel Leshin Carmel, MD
- Numéro de téléphone: +972525253037
- E-mail: danielles@bmc.gov.il
Sauvegarde des contacts de l'étude
- Nom: Pnina Nir
- E-mail: pninan@bmc.gov.il
Lieux d'étude
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Ashkelon, Israël
- Recrutement
- Barzilai Medical Center
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Contact:
- Daniel Leshin-Carmel, MD
- Numéro de téléphone: +972525253037
- E-mail: danielles@bmc.gov.il
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Contact:
- pnina nir, study coordinator
- E-mail: pninan@bmc.gov.il
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Early psychiatric intervention
Interventional arm.
Early intervention after discharge from ICU.
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Psychiatric interview for 45 minutes
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Aucune intervention: No intervention
Observational arm.
No intervention after discharge from ICU.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PTSD risk according to PCL-5
Délai: 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.
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30 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depression risk
Délai: 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.
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30 days
|
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General well being
Délai: 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.
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30 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Daniel Leshin Carmel, MD, Barzilai Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles liés aux traumatismes et aux facteurs de stress
- Les troubles mentaux
- Processus pathologiques
- Infections
- Syndrome de réponse inflammatoire systémique
- Inflammation
- Troubles de stress, traumatiques
- Conditions pathologiques, signes et symptômes
- État septique
- Troubles de stress, post-traumatique
- Troubles de combat
Autres numéros d'identification d'étude
- 0041-26-BRZ
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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