UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015653 |
|---|---|
| Receipt number | R000018114 |
| Scientific Title | The Efficacy of Perioperative Intravenous Acetaminophen for Off-pump CABG |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2016/11/13 19:32:21 |
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Basic information
Public title
The Efficacy of Perioperative Intravenous Acetaminophen for Off-pump CABG
Acronym
The Study of Acetaminophen for the Prevention Of Pain and the Reduction Of Pain-RelIever and AnTiEmetics: APPROPRIATE Study
Scientific Title
The Efficacy of Perioperative Intravenous Acetaminophen for Off-pump CABG
Scientific Title:Acronym
The Study of Acetaminophen for the Prevention Of Pain and the Reduction Of Pain-RelIever and AnTiEmetics: APPROPRIATE Study
Region
| Japan |
Condition
Condition
angina pectoris, old/subacute myocardial infarction, post operative pain
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to estimate the efficacy and the safety of preoperative intravenous acetaminophen use in off-pump coronary artery bypass grafting surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Postoperative pain scale at 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45 hours after ICU admission and at the morning of POD3,4,5 and at the discharge: including Behavioral Pain Scale, Visual Analog Scale, Numerical Rating Scale
The total amount of morphine consumption for pain reliever
The incidence of postoperative nausea and vomiting during ICU stay
Key secondary outcomes
Intra- and post-operative bleeding volume
Postoperative serum AST(aspartate aminotransferase), ALT(alanine aminotransferase), total bilirubin, alkaline phosphatase value
Postoperative blood platelet counts, prothrombin time, PT-INR, activated partial thromboplastin time
Postoperative renal function: serum creatinine level and the rate of variability against the preoperative value
The duration of mechanical ventilation
The duration of ICU stay
The progress of postoperative rehabilitation by POD3
The incidence of postoperative adverse events
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are given the study drugs 8 times every 6 hours from 30 minutes before the start of surgery to post operative day 2.
Study Drugs
Intervention group: intravenous acetaminophen 15mg/kg(1.5ml/kg, maximum dose: 1000mg)
Interventions/Control_2
Patients are given the study drugs 8 times every 6 hours from 30 minutes before the start of surgery to post operative day 2.
Study Drugs
Control group: normal saline 1.5ml/kg
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ischemic heart disease patients who have off-pump coronary artery bypass grafting surgery.
Key exclusion criteria
Fraility scale>=5
Disability of expressing pain
Patients of converting the surgery to on-pump coronary artery bypass grafting surgeries
Patients using intra-aortic balloon pumping or extracorporeal membrane oxygenation devises
The nutritionally-depleted patient: body mass index<18.5 or serum albumin level<3.5g/dl
Patients with liver disease: chronic virus hepatitis, alcoholic hepatitis, chronic cirrhosis
Preoperative blood abnormal value of AST(aspartate aminotransferase)>=120U/l, ALT(alanine aminotransferase)>=135U/l, total bilirubin>=2.4mg/dl
Hemodialysis patients
Impaired renal function: serum creatinine level>=3.0mg/dl
Patients with aspirin-induced asthma
Patients who are taking vitamin K antagonist, isoniazid, carbamazepine, phenobarbital, phenytoin, primidone, rifampicin
Patients with the allergy to acetaminophen
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Seki |
Organization
IMS Katsushika Heart Center
Division name
Anesthesiology
Zip code
Address
3-30-1 Horikiri Katsushika Tokyo, Japan
TEL
03-3694-8100
seckun@ims.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nohmi |
Organization
IMS Katsushika Heart Center
Division name
Anesthesiology
Zip code
Address
3-30-1 Horikiri Katsushika Tokyo, Japan
TEL
03-3694-8100
Homepage URL
t.nohmi@ims.gr.jp
Sponsor or person
Institute
IMS Katsushika Heart Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
イムス葛飾ハートセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018114
