Hypoactive Delirium Clinical Trial
Official title:
Effect of Flumazenil on Hypoactive Delirium in the ICU: A Double-Blind, Placebo-Controlled Pilot Study
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.
Benzodiazepines are commonly used for discomfort, anxiety, agitation, and alcohol withdrawal
syndrome (AWS) in the ICU. End organ dysfunction and extended exposure can increase the risk
of complications associated with BZDs, which include increased ICU LOS, time on mechanical
ventilation, and mortality.
Flumazenil as a 1, 4-imidazobenzodiazepine is a competitive antagonist for the benzodiazepine
binding site with weak intrinsic or partial agonistic activity on the GABA receptor. Multiple
studies have confirmed the safety and effectiveness of flumazenil for the reversal of
sedation. Pilot studies have demonstrated safe reversal of over-sedation and statistically
significant improvements in patient cooperation and time to extubation. The current standard
for suspected BZD-associated hypoactive delirium is cessation of benzodiazepine
administration and supportive care.
The role of continuous infusion flumazenil for rapid and sustained reversal of hypoactive
delirium in the ICU has not been evaluated prospectively and therefore remains poorly
defined.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03215745 -
Delirium Prevention in Patients From the Intensive Care Unit (DELA)
|
N/A | |
Recruiting |
NCT05837039 -
A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium
|
||
Recruiting |
NCT03438526 -
The Basel BOMP-AID Randomized Trial
|
Phase 4 | |
Recruiting |
NCT02345902 -
Treatment of Hypoactive Delirium and Outcome Measures
|
Phase 3 | |
Completed |
NCT03954769 -
A Pilot Study of "Stanford Proxy Test for Delirium" (S-PTD)
|
||
Not yet recruiting |
NCT05582005 -
An Observational Study of Emergence and Hypoactive Delirium After Anesthesia
|