UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029833 |
|---|---|
| Receipt number | R000034080 |
| Scientific Title | Factors Associated with the Efficacy of Intravenous Chlorpromazine for Delirium in Patients with Terminal Cancer |
| Date of disclosure of the study information | 2017/11/05 |
| Last modified on | 2017/11/05 22:02:08 |
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Basic information
Public title
Factors Associated with the Efficacy of Intravenous Chlorpromazine for Delirium in Patients with Terminal Cancer
Acronym
the Efficacy of Intravenous Chlorpromazine for Delirium
Scientific Title
Factors Associated with the Efficacy of Intravenous Chlorpromazine for Delirium in Patients with Terminal Cancer
Scientific Title:Acronym
the Efficacy of Intravenous Chlorpromazine for Delirium
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study was to evaluate factors associated with the efficacy and safety of intravenous chlorpromazine for the treatment of non-reversible delirium in end-stage cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study was identification of factors that are associated with intravenous chlorpromazine efficacy based on the comparison between clinically relevant responders and non-responders.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study focused on 97 patients who received intravenous administration of chlorpromazine as a symptomatic treatment of non-reversible delirium
Key exclusion criteria
15 patients met the exclusion criteria. The exclusion criteria included 1) the consent of intravenous administration of chlorpromazine was not obtained from their families (3 patients), 2) psychiatric disorder prohibiting communication before the onset of delirium (7 patients), 3) presence of brain tumor in the lower cortex that is contraindicated (5 patients).
Target sample size
97
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 05 | 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
NuDESC total score was significantly improved on day 3 after intravenous chlorpromazine. The chlorpromazine efficacy rate on day 3 was 0.48 (CI: 0.38-0.58). Based on the criteria of clinically relevant efficacy, the study subjects were classified into 47 responders and 50 non-responders. The responders demonstrated significantly higher hyperactive delirium rate, and higher long prognosis rate , compared with the nonresponders. Multivariable logistic regression analysis determined two relevant factors associated with intravenous chlorpromazine efficacy, which were hyperactive delirium (odds ratio : 6.25, CI: 1.14-34.5), prognosis longer than 2 weeks (odds ratio : 17.49, CI: 4.88-62.7).
By 3 days after the initial administration, 12 patients dropped out due to death (2 patients), blood pressure decreasing episode during administration (3 patients), addition of intravenous administration of benzodiazepine due to delirium progression (5 patients), acute akathisia (1 patient), and administration refusal (1 patient).
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
We retrospectively evaluated 97 end-stage cancer patients that received intravenous chlorpromazine for the treatment of non-reversible delirium.
Management information
Registered date
| 2017 | Year | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034080
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