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UMIN-CTR Clinical Trial |
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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 |
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 |
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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 |
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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 |
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Interventions/Control_1 | Intervention:
Infusion of dexmedetomidine immediately after ICU admission until 2 postoperative day(0.1-0.15 microgram/kg/hr) |
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Interventions/Control_2 | Control:
Infusion of normal saline immediately after ICU admission until 2 postoperative day |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 140 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |