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Delirium | Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium

Delirium research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Age greater than 18 years old who are admitted for more than 24 hours in the MICU or SICU - Patients diagnosed with delirium by primary team (screened positive for delirium using the CAM-ICU or with clinical manifestations of delirium) - Patients have an order for as-needed haloperidol or have received a one-time dose of haloperidol within 24 hours of randomization - Patients must be tolerating enteral feeding (greater than 20 mL/hour for more than 12 hours) Exclusion Criteria: - Patients who are unlikely to survive 24 hours after admission to the ICU - Patients who are admitted with a primary neurological condition or injury (i.e. stroke, active seizures, prolonged coma, overdose) - Patients who can not actively participate in delirium assessment - Patients actively withdrawing from alcohol or narcotics - Patients who were treated with any antipsychotic or trazodone within 30 days prior to ICU admission - Patients with a marked baseline prolongation of the QTc interval (repeated demonstration of QTc interval greater 500 milliseconds (msec)) - Patients with a history of Torsades de Pointes - Patients with current treatment with an agent having either the potential to affect or increase the risk of QTc prolongation (e.g. erythromycin, any class Ia, Ic, or III antiarrhythmics) - Patients being treated with a neuromuscular blocker - Patients in whom haloperidol, risperidone, or trazodone is contraindicated - Pregnant patients or patients who are breast-feeding - Patients with a modified Blessed dementia rating scale score ≥4 or an Informant Questionnaire of Cognitive Dysfunction in the Elderly Score ≥4 - Patients in which informed consent can not be obtained from the legally authorized representative

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Delirium

Agitation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Risperidone

Drug:Trazodone

Drug:Placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboDrug: Placebo Placebo suspension administered PO/NG/FT q12h to mimic risperidone Placebo suspension administered PO/NG/FT q8h to mimic trazodone

Risperidone aloneDrug: Risperidone Initiate risperidone at 1 mg PO/NG/FT q12h Risperidone dose can be titrated upwards every 24 hours by increments of 0.5 mg per dose Maximum risperidone daily dose of 6 mg per day (3 mg every 12 hours)

Trazodone aloneDrug: Trazodone Initiate trazodone dosing at 50 mg PO/NG/FT q8h Trazodone dose can be titrated upwards every 24 hours by 25 mg per dose Maximum trazodone daily dose 600 mg per day (200 mg every 8 hours)

Risperidone and Trazodone combinationDrug: Risperidone Initiate risperidone at 1 mg PO/NG/FT q12h Risperidone dose can be titrated upwards every 24 hours by increments of 0.5 mg per dose Maximum risperidone daily dose of 6 mg per day (3 mg every 12 hours) Drug: Trazodone Initiate risperidone at 1 mg PO/NG/FT q12h Risperidone dose can be titrated upwards every 24 hours by increments of 0.5 mg per dose Maximum risperidone daily dose of 6 mg per day (3 mg every 12 hours)

Study Status

Terminated

Start Date: March 2011

Completed Date: March 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The number of days patients are without delirium during the study period (delirium-free days)

Secondary Outcome: Daily prevalence of delirium as indicated by a positive Confusion Assessment Method in the ICU (CAM-ICU)

Study sponsors, principal investigator, and references

Principal Investigator: Mindee S Hite, Pharm.D.

Lead Sponsor: Rochester General Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02118688

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