Delirium
Conditions
Interventions
Intervention Group:Participants will receive either tributyrin (providing 875 mg butyrate in 5 mL, totaling 2.625 g/day). The intervention will be administered via nasogastric tube three times daily f
Placebo Group :An equal volume of placebo that is indistinguishable in appearance, taste, and smell The placebo will be administered via nasogastric tube three times daily for up to 14 days or until I
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adult patients (>=18 years) expected to require mechanical ventilation for longer than 24 hours 2.Stay in ICU >=72 hours, and with a nasogastric tube. 3. Recruitment within 48 hours of invasive mechanical ventilation initiation 4. Written informed consent obtained from next of kin.
Exclusion criteria
Exclusion criteria: 1. Invasive mechanical ventilation of more than 48 hours prior to randomization; 2. Pregnancy and lactation 3. Hearing impairment, non-Chinese / English speakers, severe dementia (Mini Mental State < 20), psychosis, alcohol withdrawal syndrome or delirium at/before randomization; 4. Absence of nasogastric tube or contraindications to use the gastrointestinal tract for medication administrations; 5. Moribund patient or expected death within 14 days; under guardianship or curatorship; 6. Participation in another interventional delirium-focused study; known adverse reactions to butyrate or prior butyrate, probiotics, or synbiotics use within 14 days before enrollment; 7. ICU admission due to cardiac arrest, stroke, traumatic brain injury, neurosurgical diagnoses, or prior antipsychotic use or with known neurodegenerative diseases such as Alzheimer's disease and Parkinsonism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Analysis ;Gut microbiome analysis;Delirium Assessment ;Acute Kidney Injury Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival status, healthcare-associated infections (HAIs) events, and hospital length of stay;Survival status and Days Alive and at Home at Day-90; | — |
Countries
China
Contacts
Public ContactHo Kwok Ming
The Chinese University of Hong Kong, Department of Acute Intensive Care
Outcome results
None listed