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:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02899156
Eligibility Criteria:
Inclusion Criteria:
* critically ill adults
* RASS score of -3 to 0 after receiving benzodiazepine therapy
* CAM-ICU positive
* no benzodiazepine therapy within the previous 12 hours
Exclusion Criteria:
1. contraindications to flumazenil including hypersensitivity
2. receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
3. active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
4. history of traumatic brain injury complicated by seizures
5. acute episode (within prior 30 days) of severe traumatic brain injury
6. history of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage) complicated by seizures
7. acute episode (within prior 14 days) of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage)
8. brain tumor complicated by seizure
9. history of anoxic brain injury
10. third-degree burn with total body surface area (TBSA) burn greater than 20%
11. chronic benzodiazepine (clonazepam:lorazepam:diazepam approximately 4:8:40 mg per day) for 7 consecutive days with no taper
12. chronic delirium that is attributable to other causes
13. anticipated to transfer to lower level of care within 24 hours
14. admitted for polysubstance overdose as determined by initial drug toxicity screening
15. recent exposure (prior 7 days) to pro-convulsant medications (identified via medication list, medication reconciliation performed by PI/pharmacy medication reconciliation team, or urine drug screening)
16. children, incarcerated individuals, and pregnant women
17. unable to provide consent and the legally authorized representative is unable to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02899156
Study Brief:
Protocol Section:
NCT02899156