Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05232734
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (≥ 21 years old),
2. Patients with encephalopathy (GCS ≤ 8) limiting extubation, where encephalopathy is deemed by clinician to be unresponsive to treatment or not eligible for treatment to reverse the encephalopathy (eg. transplantation) or if no treatment exists, and
3. Patients who are not planned for any surgical procedures within 24 hours
4. Patients who are not on sedative agents for at least 24 hours (exception for low dose fentanyl of up to 30mcg/h and dexmedetomidine of up to 0.5mcg/kg/h for analgesia/sedation/tube tolerance)
* For patients with primary CNS lesions, neurologist or neurosurgeon approval will be obtained prior to recruitment.
Exclusion Criteria:
1. Known allergy or adverse reactions from caffeine,
2. Pregnant women,
3. Breast-feeding women,
4. Patients with uncontrolled cardiac arrhythmias,
5. Patients with uncontrolled hypertension,
6. Patients with hyperactive delirium,
7. Patients with chronic kidney disease (CKD, any stage) who received midazolam or morphine infusion during their ICU stay,
8. Patients who received barbiturate coma,
9. Patients who are on theophylline, aminophylline or psychotropic agents at the point of screening for recruitment,
10. Patients with feed intolerant, short bowel syndrome, or
11. Patients with active seizures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
130 Years
Study:
NCT05232734
Study Brief:
Protocol Section:
NCT05232734