UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Efficacy of Perioperative Intravenous Acetaminophen for Off-pump CABG
Title of the study (Brief title)	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	Koichiro Seki
Organization	IMS Katsushika Heart Center
Division name	Anesthesiology
Address	3-30-1 Horikiri Katsushika Tokyo, Japan
TEL	03-3694-8100
Email	seckun@ims.gr.jp

Public contact
Name of contact person	Toshihiro Nohmi
Organization	IMS Katsushika Heart Center
Division name	Anesthesiology
Address	3-30-1 Horikiri Katsushika Tokyo, Japan
TEL	03-3694-8100
Homepage URL
Email	t.nohmi@ims.gr.jp

Sponsor
Institute	IMS Katsushika Heart Center
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018114