A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients

A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients - The structured psychotropic drugs intervention for hyperactive delirium

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040146

Enrollment

Registered

2020-04-13

Start date

2020-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hospitalized patients aged 18 years or older. 2) Cancer patients diagnosed as having locally advanced or distant metastases by any of histological, cytological, and clinical diagnosis. 3) Patients who are diagnosed with hyperactive/mixed delirium based on the criteria of DSM-5 and who use psychotropic drugs (injection drug) for restlessness/agitation (RASS + 1 or higher). 4) Delirium is clinically determined by the attending physician to be irreversible. 5) Patients who are examined by a physician in a palliative care unit/palliative care team.

Exclusion criteria

Exclusion criteria: 1) Patients for whom psychotropic drugs are contraindicated. 2) Patients who indicated that they would refuse to participate in this study. 3) Patients judged to be inappropriate by the attending physician.

Design outcomes

Primary

Measure	Time frame
The proportion of patients receiving structured psychotropic drugs intervention for hyperactive/mixed delirium at 3 days after (T2). If not, the reason for discontinuation.	—

Secondary

Measure	Time frame
The proportion of patients receiving structured psychotropic drugs intervention for hyperactive/mixed delirium at 1 day (T1), 7days (T3), 14 days (T4), 21days (T5) after and the day of death (T6). If not, the reason for discontinuation. The proportion of patients who achieved treatment goals at T1 to T6. The proportion of patients who changed their psychotropic treatment regimen for hyperactive/mixed delirium and their reasons, type and dosage of psychotropic drugs at T1 to T6. The proportion and reason of patients receiving continuous sedation, type and dosage of sedatives at T1 to T6. The proportion of patients receiving additional drugs other than psychotropic treatment regimens, reasons for adding other drugs, and types of additional drugs at T1 to T6. The scores of the Richmond Agitation-Sedation Scale (RASS), Agitation Distress Scale (ADS) item2, Communication Capacity Scale item4, delirium symptoms, and respiratory rate at T1 to T5. Psychotropic drug-related adverse events at T2 and T3 (CTCAE v5.0) The outcome at T1 to T5, and 2 months after treatment. (Alive or dead)	—

Measure

Time frame

The proportion of patients receiving structured psychotropic drugs intervention for hyperactive/mixed delirium at 1 day (T1), 7days (T3), 14 days (T4), 21days (T5) after and the day of death (T6). If not, the reason for discontinuation. The proportion of patients who achieved treatment goals at T1 to T6. The proportion of patients who changed their psychotropic treatment regimen for hyperactive/mixed delirium and their reasons, type and dosage of psychotropic drugs at T1 to T6. The proportion and reason of patients receiving continuous sedation, type and dosage of sedatives at T1 to T6. The proportion of patients receiving additional drugs other than psychotropic treatment regimens, reasons for adding other drugs, and types of additional drugs at T1 to T6. The scores of the Richmond Agitation-Sedation Scale (RASS), Agitation Distress Scale (ADS) item2, Communication Capacity Scale item4, delirium symptoms, and respiratory rate at T1 to T5. Psychotropic drug-related adverse events at T2 and T3 (CTCAE v5.0) The outcome at T1 to T5, and 2 months after treatment. (Alive or dead)

—

Countries

Japan

Contacts

Public ContactKengo Imai

Seirei Mikatahara General Hospital Seirei Hospice

k.imai@sis.seirei.or.jp0534361251

Outcome results