UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020382 |
|---|---|
| Receipt number | R000023539 |
| Scientific Title | The effectiveness of scheduled intra venous acetaminophen in cardiac surgery |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2020/07/03 14:55:38 |
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Basic information
Public title
The effectiveness of scheduled intra venous acetaminophen in cardiac surgery
Acronym
The effectiveness of scheduled intra venous acetaminophen in cardiac surgery
Scientific Title
The effectiveness of scheduled intra venous acetaminophen in cardiac surgery
Scientific Title:Acronym
The effectiveness of scheduled intra venous acetaminophen in cardiac surgery
Region
| Japan |
Condition
Condition
angina pectoris, myocardial infarction
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore the effectiveness of intravenous acetaminophen in cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to first dose of rescue non-steroidal antiinflammatory medicine after discontinuation of opioid.
Key secondary outcomes
Scores in face-scales in the intensive care unit.
Dose of opioid in the intensive care unit.
Dose of non-steroidal anti-inflammatory medicine for two and three days post-operatively.
Complaint of pain in the floor.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We will give 1000mg (or 15mg/kg for the patients who weights less than 50kg) of i.v. acetaminophen for every 6 hours for 12 doses.
The duration will be 3 days.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elective coronary artery bypass surgery
Age; less than or equal to 20, older than 80 years old
The patient who agreed to undergo the study.
Key exclusion criteria
Age younger than 20, Age older than or equal to 80 years old
Emergency surgery
BM more than or equal to 35
LVEF less than35%
serum creatinine more than 2.0mg/dl
AST/ALT more than 1.5times normal
coagulopathy
Acute myocardial infarction
History of stroke within 6 months
Severe COPD
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Usui |
Organization
Nagoya University graduate school of Medicine
Division name
Department of Cardiac Surgery
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
81-52-744-2376
ausui@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonobu |
| Middle name | |
| Last name | Abe |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiac Surgery
Zip code
371-8511
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
81527442376
Homepage URL
tomonobuabe@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Cardiac Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate 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
Nagoya University
Address
Tsurumaicho, Showaku Nagoya
Tel
052-741-2111
tomonobu_abe@med.nagoya-u.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | 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
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023539
| Research Plan | |
|---|---|
| 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 |
