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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020382
Receipt No. 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

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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
Email 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
Email tomonobuabe@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Cardiac Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023539

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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