Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metast… (NCT03021486) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer
United States70 participantsStarted 2017-06-05
Plain-language summary
This randomized phase II/III trial studies how well haloperidol with or without chlorpromazine works in treating delirium in patients with cancer that has spread to other parts of the body or has come back. Haloperidol and chlorpromazine may control the symptoms of delirium (loss of contact with reality) in patients with cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
✓. \[Patients\] Admitted to the acute palliative care unit
✓. \[Patients\] Delirium as per DSM-V criteria (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5))
✓. \[Patients\] Hyperactive or mixed delirium with RASS \>/=1 in the past 24 h (RASS\>/=+1 indicates any degree of restlessness. In the electronic medical record nursing note, this behavior would be indicated by any documentation of "restless", "agitated", "hyperactive", "pulling on devices/IV" or similar wording).
✓. \[Patients\] On scheduled haloperidol for delirium (\</=8 mg in the past 24 h) or rescue haloperidol of \>/=4 mg for restlessness/agitation in the past 24 h
✓. \[Patients\] Age 18 years or older
✓. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
✓. \[Family Caregivers\] Age 18 years or older
Exclusion criteria
✕. \[Patients\] History of myasthenia gravis or acute narrow angle glaucoma
✕. \[Patients\] History of neuroleptic malignant syndrome or active seizure disorder (with seizure episode within the past week)
✕. \[Patients\] History of Parkinson's disease or Alzheimer's dementia
What they're measuring
1
Change in Richmond Agitation Sedation Score (RASS) (0-24h)
Timeframe: Time 0 or Baseline and 24 hours after study medication administration