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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030920
Receipt No. 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 2019/07/24

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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
Email 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
Email ojikino2@a5.keio.jp

Sponsor
Institute Department of Anesthesiology, Keio University School of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 14 Day
Date of IRB
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
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035307

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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