UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040146
Receipt number R000045776
Scientific Title A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients
Date of disclosure of the study information 2020/04/13
Last modified on 2020/04/13 18:22:35

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Basic information

Public title

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

Acronym

The structured psychotropic drugs intervention for hyperactive delirium

Scientific Title

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

Scientific Title:Acronym

The structured psychotropic drugs intervention for hyperactive delirium

Region

Japan


Condition

Condition

Cancer

Classification by specialty

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore the feasibility of structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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

Key secondary outcomes

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)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kengo
Middle name
Last name Imai

Organization

Seirei Mikatahara General Hospital

Division name

Seirei Hospice

Zip code

433-8558

Address

3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 433-8558 Japan

TEL

+81534361251

Email

k.imai@sis.seirei.or.jp


Public contact

Name of contact person

1st name Kengo
Middle name
Last name Imai

Organization

Seirei Mikatahara General Hospital

Division name

Seirei Hospice

Zip code

433-8558

Address

3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 433-8558 Japan

TEL

0534361251

Homepage URL


Email

k.imai@sis.seirei.or.jp


Sponsor or person

Institute

Seirei Mikatahara General Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Seirei Mikatahara General Hospital

Address

3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 4338558 Japan

Tel

0534361251

Email

mkwebmaster@sis.seirei.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

1958

Org. issuing International ID_1

Seirei Mikatahara General Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2020 Year 01 Month 08 Day

Date of IRB

2020 Year 01 Month 20 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Research period: January 2020 (after approval by the Ethics Committee)-March 2024 (including the analysis period)


Management information

Registered date

2020 Year 04 Month 13 Day

Last modified on

2020 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name