UMIN-CTR Clinical Trial

Basic information
Public title	The effect of intravenous acetaminophen on postoperative temperature after cardiac surgery with cardiopulmonary bypass
Acronym	The effect of acetaminophen on postoperative temperature after cardiac surgery
Scientific Title	The effect of intravenous acetaminophen on postoperative temperature after cardiac surgery with cardiopulmonary bypass
Scientific Title:Acronym	The effect of acetaminophen on postoperative temperature after cardiac surgery
Region	Japan

Condition
Condition	Patients after cardiac surgery
Classification by specialty	Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of intravenous acetaminophen on postoperative temperature after cardiac surgery with cardiopulmonary bypass
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The highest temperature during 24 hours after ICU admission
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acetaminophen is administered intravenously every 6 hours since 30 minutes after weaning from cardiopulmonary bypass. The amount of acetaminophen is 15 mg/kg. ( maximal dose: 1000mg )
Interventions/Control_2	Physiological saline is administered intravenously every 6 hours since 30 minutes after weaning from cardiopulmonary bypass. The amount of physiological saline is 1.5 mL/kg. ( maximal dose: 100mL )
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	Patients admitted to Nagasaki University Hospital to receive elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria	1. preoperative liver dysfunction ( ALT > = 126 U/L or Child-Pugh score A, B or C) 2. preoperative renal dysfunction ( eGFR < = 30 mL/min/1.73m^2) 3. patients with allergic history against acetaminophen 4. patients with peptic ulcer 5. patients with severe hematologic disease 6. patients with history of aspirin-induced asthma 7. pregnant or breast-feeding women 8. preoperative use of steroids 9. re-operated patients 10. patients with re-induction of cardiopulmonary bypass during operation 11. patients undergoing re-operation because of postoperative hemorrhage 12. patients judged inappropriate
Target sample size	48

Research contact person
Name of lead principal investigator	1st name SOJIRO Middle name Last name MATSUMOTO
Organization	Nagasaki University Hospital
Division name	Division of intensive care
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7200
Email	s-matsumoto@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name SOJIRO Middle name Last name MATSUMOTO
Organization	Nagasaki University Hospital
Division name	Division of intensive care
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL	095-819-7200
Homepage URL
Email	s-matsumoto@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel	095-819-7200
Email	s-matsumoto@nagasaki-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	2018 Year 06 Month 21 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	2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date	2023 Year 01 Month 01 Day
Last follow-up date	2024 Year 03 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	2018 Year 06 Month 20 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037696