UMIN-CTR Clinical Trial

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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