Abstract
BackgroundDelirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms.Methods/DesignThis is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted to the ICU of Wishard Memorial Hospital in Indianapolis. Subjects assigned to the intervention group will receive a multicomponent pharmacological management protocol for delirium (PMD) and those assigned to the control group will receive no change in their usual ICU care. The primary outcomes of the trial are (1) delirium severity as measured by the Delirium Rating Scale revised-98 (DRS-R-98) and (2) delirium duration as determined by the Confusion Assessment Method for the ICU (CAM-ICU). The PMD protocol targets the three neurotransmitter systems thought to be compromised in delirious patients: dopamine, acetylcholine, and gamma-aminobutyric acid. The PMD protocol will target the reduction of anticholinergic medications and benzodiazepines, and introduce a low-dose of haloperidol at 0.5-1 mg for 7 days. The protocol will be delivered by a combination of computer (artificial intelligence) and pharmacist (human intelligence) decision support system to increase adherence to the PMD protocol.DiscussionThe proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU.Trial RegistrationClinicalTrials.gov: NCT00842608
Highlights
Delirium prevalence in the intensive care unit (ICU) is high
Despite the lack of evidence, clinicians that care for these patients often use typical and atypical antipsychotics, benzodiazepines, and other sedatives to manage the symptoms of delirium [20,21]
The available literature suggests a therapeutic role for acetylcholine enhancement, gamma-aminobutyric acid (GABA) reduction, and dopamine reduction [9,10,11,12,15,22], which is reflected in available clinical practice guidelines for delirium management [4]
Summary
In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU) costing Medicare an estimated $27.5 billion [1,2,3]. Despite the lack of evidence, clinicians that care for these patients often use typical and atypical antipsychotics, benzodiazepines, and other sedatives to manage the symptoms of delirium [20,21] This approach conflicts with our current understanding of the neurotransmitter balance in delirium. The available literature suggests a therapeutic role for acetylcholine enhancement, gamma-aminobutyric acid (GABA) reduction, and dopamine reduction [9,10,11,12,15,22], which is reflected in available clinical practice guidelines for delirium management [4] This neurotransmitter model supports a combination intervention that includes avoiding or reducing the use of benzodiazepines and anticholinergics, and the use of low dose antipsychotics such as haloperidol [4,23,24,25,26]. The secondary hypothesis theorizes that the study intervention will result in (1) shorter hospital lengths of stay, (2) lower ICU, hospital, and 30-day mortality, and (3) lower hospital-acquired complications related to delirium
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