๐ฌIn plain words
What the trial is, and whether it could suit you
Delirium in the intensive care unit (ICU) is a prevalent and serious neurological complication among critically ill patients, with large multicenter studies reporting an incidence of 30% to 80%, particularly in those requiring mechanical ventilation. Delirium is not only associated with prolonged ICU and hospital stays but also with increased morbidity and mortality. Notably, up to 40% of survivors suffer from persistent cognitive dysfunction that may last for months or even years. Despite current standard pharmacological interventions-such as haloperidol and second-generation antipsychotics-failing to demonstrate significant clinical benefit in phase III trials, non-pharmacological strategies remain challenging to implement due to environmental and operational constraints within the ICU. This unmet clinical need underscores the imperative to develop novel, effective therapeutic approach
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 1\. Age โฅ 18 years old, no ethnic or gender restrictions;
* 2\. CAM-ICU-positive delirium;
* 3\. Expected ICU stay โฅ 5 days after inclusion in the study;
* 4\. Signed written informed consent.
Exclusion Criteria:
* 1\. Routine administration of antipsychotic medications: Conventional antipsychotic therapy refers to the daily ingestion or application of any sustained-release formulation (in any dosage form) of antipsychotic drugs with the ATC code N05A (in any form), including the following agents:
1. Typical antipsychotics: Chlorprothixene, Flupentixol, Haloperidol, Levomepromazine, Loxapine, Melperone, Perphenazine, Pericyazine, Pimozide, Prochlorperazine, Zuclopenthixol, Pimavanserin, Sulpiride.
2. Atypical antipsychotics: Amisulpride, Aripiprazole, Asenapine, Clozapine, Lurasidone, Olanzapine, Paliperidone, Quetiapine, Risperidone, Sertindole, Ziprasidone. However, the non-habitual administration of antipsychotic medications in the general ward prior to the patient's ICU admission (e.g., for the management of delirium) is deemed acceptable. Nevertheless, antipsychotic therapy should be discontinued upon the patient's ICU admission.
* 2\. Severe systemic infection in the early stage of resuscitation, hemodynamic instability or insufficient tissue perfusion, and severe imbalance of water, electrolyte and acid-base.
* 3\. Patients with a high risk of death within 5 days as judged by the clinician, or those whose treatment decisions are restricted.
* 4\. Active major gastrointestinal bleeding, perforation, or other severe damage to the intestinal barrier.
* 5\. Patients who cannot tolerate 50% of their caloric requirements through enteral nutrition due to severe diarrhea, significant fibrotic intestinal stenosis, severe gastrointestinal bleeding, or high-flow enteric fistula.
* 6\. Planned or recent abdominal surgery (within 14 days).
* 7\. Currently diagnosed with fulminant colitis or toxic megacolon.
* 8\. Recently received high-risk immunosuppressive or cytotoxic drug treatment: such as rituximab, doxorubicin, or medium to high-dose corticosteroids (20 mg/d prednisone or higher) for more than 4 weeks.
* 9\. Pregnant or lactating women.
* 10\. Participated in other clinical trials as a subject within the past 3 months or at the time of enrollment.
* 11\. Delirium assessment non applicable: this includes language barriers (patients with foreign language where delirium assessment cannot be confidently performed by the site staff), patients who are deaf, blind or aphasic. Comatose patients are not applicable for delirium assessment. Coma is defined by the following levels of consciousness: RASS -4 to -5. Further, RASS -3 may be considered as coma if this is the judgement of the treating physician. If a patient's coma is considered related to administration of sedative agents, an effort should be made to reduce or terminate the sedative treatment, according to the clinician's discretion.
* 12\. Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that limit the validity of informed consent for participation in this study.