Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT05431595
Eligibility Criteria:
Inclusion Criteria:
1. \[Patients\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)
2. \[Patients\] Seen by palliative care inpatient consultation team
3. \[Patients\] Delirium as per DSM-5 criteria
4. \[Patients\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium
5. \[Patients\] Age 18 years or older
6. \[Patients\] Permission from clinician from primary team to enroll
7. \[Family Caregivers\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)
8. \[Family Caregivers\] Age 18 years or older
Exclusion Criteria:
1. \[Patients\] On scheduled haloperidol \>4 mg/d, chlorpromazine \>100 mg/d, or valproate \>750 mg/d
2. \[Patients\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart
3. \[Patients\] Hepatic dysfunction (unresolved AST or ALT \>2.5x ULN, bilirubin \>1.5x ULN or INR \>1.5 within past month)
4. \[Patients\] History of neuroleptic malignant syndrome as documented in chart
5. \[Patients\] Active seizure disorder within past month as documented in chart
6. \[Patients\] History of Parkinson's disease or dementia as documented in chart
7. \[Patients\] History of prolonged QTc interval (\>500 ms) if documented by most recent ECG within the past month
8. \[Patients\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart
9. \[Patients\] Pancreatitis within past month as documented in chart
10. \[Patients\] Currently on lamotrigine, phenobarbital, or carbamazepine
11. \[Patients\] Physical signs of impending death such as respiration with mandibular movement and death rattle
12. \[Patients\] Pregnancy as documented in chart
13. \[Patients\] Active COVID-19 infection as documented in chart
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05431595
Study Brief:
Protocol Section:
NCT05431595