Hypoactive Delirium Clinical Trial
— FLYPOfficial title:
Effect of Flumazenil on Hypoactive Delirium in the ICU: A Double-Blind, Placebo-Controlled Pilot Study
NCT number | NCT02899156 |
Other study ID # | 837421 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 16, 2019 |
Verified date | July 2020 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Delirium within the intensive care unit (ICU) is associated with poor outcomes such as
increased mortality, ICU and hospital length of stay (LOS), and time on mechanical
ventilation. Benzodiazepine (BZD) exposure is an independent risk factor for development of
delirium. Reversal of hypoactive delirium represents a potential opportunity for reducing
duration of delirium and subsequent complications.
This is a single-center randomized, double-blind, placebo-controlled study of critically ill
adult patients with benzodiazepine-associated hypoactive delirium. The hypothesis is that
flumazenil continuous infusion may reverse hypoactive delirium associated with BZD exposure
and thereby reduce duration of delirium and ICU LOS.
Status | Terminated |
Enrollment | 22 |
Est. completion date | April 16, 2019 |
Est. primary completion date | April 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Delirium-free Days | Defined by the number of days in the 14-day period after randomization that the patient was alive and not delirious (i.e. CAM-ICU negative). Zero delirium-free days will be observed for patients that die within the 14-day period. | up to 14 days after randomization | |
Secondary | Number of Participants With Delirium Resolution | defined by the proportion of patients who were delirium free at 14 days after randomization | up to 14 days after randomization | |
Secondary | Intensive Care Unit Length of Stay | length of time that the patient was admitted to an intensive care unit service during the hospital stay | duration of admission to the intensive care unit | |
Secondary | Number of Mechanical Ventilator Free Days | number of days within the first 28 days after enrollment that the patient was free from needing mechanical ventilation | up to 28 days after randomization | |
Secondary | Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | number of times that a RASS score of + 2 to +4 occurred that did not resolve with decreasing study infusion | up to 72 hours after the start of the infusion | |
Secondary | Average Duration of Study Infusion | average duration of time patient was randomized to each infusion up to 72 hours | up to 72 hours after the start of the infusion | |
Secondary | Average Maximum Rate of Study Infusion | average maximum rate (ml/hr) during the 72 hours after study infusion | up to 72 hours after the start of the infusion |
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