Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hypoactive Delirium

In brief

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.

Key facts

Study ID

NCT02899156

Run by

University of California, Davis

People needed

22

Starts

2016-03-01

Expected to finish

2019-04-16

Last updated by the study team

2020-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• critically ill adults
• RASS score of -3 to 0 after receiving benzodiazepine therapy
• CAM-ICU positive
• no benzodiazepine therapy within the previous 12 hours

You may not qualify if…

• contraindications to flumazenil including hypersensitivity
• receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
• active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
• history of traumatic brain injury complicated by seizures
• acute episode (within prior 30 days) of severe traumatic brain injury
• history of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage) complicated by seizures
• acute episode (within prior 14 days) of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage)
• brain tumor complicated by seizure
• history of anoxic brain injury
• third-degree burn with total body surface area (TBSA) burn greater than 20%
• chronic benzodiazepine (clonazepam:lorazepam:diazepam approximately 4:8:40 mg per day) for 7 consecutive days with no taper
• chronic delirium that is attributable to other causes
• anticipated to transfer to lower level of care within 24 hours
• admitted for polysubstance overdose as determined by initial drug toxicity screening
• 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)
• children, incarcerated individuals, and pregnant women
• unable to provide consent and the legally authorized representative is unable to provide consent

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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