The purpose of this randomized clinical trial is to determine whether risperidone alone, trazodone alone, or a combination of risperidone and trazodone is superior for the treatment of ICU acquired delirium. The hypothesis is that combination therapy is superior to either agent alone in treating ICU acquired delirium and sustaining delirium free time.
Delirium is defined as a disturbance of consciousness characterized by an acute onset of impaired cognitive function. Although delirium is thought to be common in the Intensive Care Unit (ICU) there are few studies that have evaluated its incidences, risks and outcomes. It has been associated with increased morbidity, and mortality and increased cost to the healthcare system. In addition to the uncertainty of the incidence of ICU delirium, there is a lack of information about the effects that certain pharmacological treatments have on delirious patients. The rationale for this study is to evaluate the efficacy and safety of risperidone alone, trazodone alone, and risperidone plus trazodone for the treatment of delirium in critically ill patients when compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Rochester General Hospital
Rochester, New York, United States
The number of days patients are without delirium during the study period (delirium-free days)
The number of days patients are without delirium during the study period (delirium-free days)
Time frame: Every 24 hours (up to 14 days)
Daily prevalence of delirium as indicated by a positive Confusion Assessment Method in the ICU (CAM-ICU)
Time frame: Every 24 hours (up to 14 days)
Resolution of delirium as indicated by a negative Confusion Assessment Method in the ICU (CAM-ICU) for more than 24 hours
Time frame: Every 24 hours (up to 14 days)
The number of patients who require rescue medications, the type of rescue medications utilized, and the amount of rescue medications per day
Time frame: Every 24 hours (up to 14 days)
The number of patients who receive sedative agents, amount of midazolam equivalents per day, and the number of days in which patients receive a sedative agent
Time frame: Every 24 hours (up to 14 days)
The number of patients who receive pain medications, amount of fentanyl equivalents per day, and the number of days in which patients receive a pain medication
Time frame: Every 24 hours (up to 24 hours)
The number of hours spent agitated (RASS score between +4 and +2) as a percent of the time that the study drug was administered
Time frame: Every 24 hours (up to 14 days)
The number of hours spent excessively sedated or in a coma state (RASS score between -4 to -5) as a percent of the time that the study drug was administered
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Every 24 hours (up to 14 days)
The duration of mechanical ventilation from initial intubation to extubation as long as the patient remained extubated for more than 48 hours.
Time frame: Time (hours) from initial intubation to extubation (as long as patient not reintubated within 48 hours)
The number of days that the patients were alive and breathing without assistance during the study period (ventilator-free days)
Time frame: Time (days) from extubation to patient discharge (as long as patient not reintubated within 48 hours)
The number of episodes and number of patients who experience clinically significant QTc prolongation (≥ 500 msec or an increase of more than 60 msec from baseline)
Time frame: QTc interval evaluated q12h during period of study drug administration (up to 14 days)
The number of episodes and number of patients who experience clinically significant extrapyramidal effects (as evidenced by a positive Simpson-Angus Scale Score)
Time frame: Extrapyramidal effects evaluated by bedside nurse q12h during period of study drug administration (up to 14 days). Investigator will confirm RN suspicion of extrapyramidal effects using Simpson-Angus Score.
All-cause mortality and 28-day mortality
Time frame: At 14 and 28 days