UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030920 |
|---|---|
| Receipt number | R000035307 |
| Scientific Title | Evaluation of the effect of dexmedetomidine on the incidence of delirium in patients after cardiovascular surgery: A randomized placebo-controlled trial |
| Date of disclosure of the study information | 2018/01/23 |
| Last modified on | 2022/01/24 12:52:06 |
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Basic information
Public title
Evaluation of the effect of dexmedetomidine on the incidence of delirium in patients after cardiovascular surgery: A randomized placebo-controlled trial
Acronym
Evaluation of the effect of dexmedetomidine on the incidence of delirium
Scientific Title
Evaluation of the effect of dexmedetomidine on the incidence of delirium in patients after cardiovascular surgery: A randomized placebo-controlled trial
Scientific Title:Acronym
Evaluation of the effect of dexmedetomidine on the incidence of delirium
Region
| Japan |
Condition
Condition
Patients more than or equal to 65 years old, who undergo cardiovascular surgery for valvular or coronary artery diseases under cardiopulmonary bypass with cardiac arrest
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether dexmedetomidine can reduce the incidence of delirium in patients undergoing cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of delirium until 2 postoperative day
Key secondary outcomes
The incidence of delirium until 5 postoperative day
The rate of haloperidol or risperidone use for delirium
The duration of invasive mechanical ventilation
The rate and duration of noninvasive ventilation
The rate of intra-aortic balloon pumping or extracorporeal membrane oxygenation management
The rate of duration in which the targetted sedation level evaluated by Richmond agitation sedation scale was achieved
The dose of catecholamines used
The rate and volume of blood transfusion
The degree of pain evaluated by Numerical rating scale during ICU stay
Cognitive function evaluated by Mini mental state examination at 7 postoperative day
Duration of ICU stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:
Infusion of dexmedetomidine immediately after ICU admission until 2 postoperative day(0.1-0.15 microgram/kg/hr)
Interventions/Control_2
Control:
Infusion of normal saline immediately after ICU admission until 2 postoperative day
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients more than or equal to 65 years old, who undergo cardiovascular surgery for valvular diseases or coronary artery diseases under cardiopulmonary bypass with cardiac arrest
Key exclusion criteria
Patients diagnoses as schizophrenia or depression
Patients with liver cirrhosis
Patients under dialysis management
Patient with heart rate less than 50/min
Patients with severe dementia
Patient without communication ability
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morisaki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
morisaki@z8.keio.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Nagata |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
ojikino2@a5.keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Keio University School of Medicine
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
Ethics committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3611
med-rinri-jimu@adst.keio.ac.jp
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035307
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
