UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035517 |
|---|---|
| Receipt number | R000040464 |
| Scientific Title | The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay. A Randomised Controlled Trial |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2021/12/31 17:16:34 |
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Basic information
Public title
The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial
Acronym
The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial
Scientific Title
The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial
Scientific Title:Acronym
The efficacy of continuous administration of low-dose ketamine during elective on-pump cardiac surgery on hospital length of stay.
A Randomised Controlled Trial
Region
| Japan |
Condition
Condition
Valvular heart disease and ischaemic heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Continuous administration of low-dose ketamine during elective on-pump cardiac surgery shortens the hospital length of stay after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the hospital length of stay after surgery
Key secondary outcomes
Occurrence of delirium
Occurrence of postoperative atrial fibrillation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control group
Interventions/Control_2
continuous administration of low-dose ketamine group
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elective valve surgery (mitral valve/aortic valve) and/or coronary artery bypass surgery with a cardiopulmonary bypass
Key exclusion criteria
Emergency surgery
Redo
Minimally invasive cardiac surgery
carrying ICD
patients who have been diagnosed with cancer
ASA PS 4, 5, 6
Uncontrolled diabetes mellitus
Severe pulmonary diease, asthmatic attack
Current smoker
Hepatic impairment (Child-Pugh A,B,C or aspartate aminotransferase or alanine aminotransferase more than twice the upper normal limit)
Chronic renal insufficiency:serum creatinine level > 2 mg/dL
Immunosuppressive medication (e.g. glucocorticoids)
Cognitive dysfunction, Psychiatric impairment, depression, Parkinson disease, Cerebrovascular disease
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Usuda |
Organization
Saitama Cardiovascular and Respiratory Centre
Division name
Anaesthesiology
Zip code
360-0105
Address
Itai 1696, Kumagaya-city, Saitama 360-0105
TEL
048-536-9900
iusuda-tmhp@umin.ac.jp
Public contact
Name of contact person
| 1st name | General Affairs Department |
| Middle name | |
| Last name | Saitama Cardiovascular and Respiratory Centre |
Organization
Saitama Cardiovascular and Respiratory Centre
Division name
General Affairs Department
Zip code
360-0105
Address
Itai 1696, Kumagaya-city, Saitama 360-0105
TEL
048-536-9900
Homepage URL
k369900@pref.saitama.lg.jp
Sponsor or person
Institute
Saitama Cardiovascular and Respiratory Centre
Institute
Department
Personal name
Funding Source
Organization
Saitama prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Affairs Department of Saitama Cardiovascular and Respiratory Centre
Address
Itai 1696, Kumagaya-city, Saitama 360-0105
Tel
048-536-9900
k369900@pref.saitama.lg.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
埼玉県立循環器・呼吸器病センター/Saitama Cardiovascular and Respiratory Centre
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 11 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040464
