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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033064
Receipt No. R000037696
Scientific Title The effect of intravenous acetaminophen on postoperative temperature after cardiac surgery with cardiopulmonary bypass
Date of disclosure of the study information 2018/06/21
Last modified on 2018/06/20

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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
Middle name
Last name SOJIRO MATSUMOTO
Organization Nagasaki University Hospital
Division name Division of intensive care
Zip code
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
Middle name
Last name SOJIRO MATSUMOTO
Organization Nagasaki University Hospital
Division name Division of intensive care
Zip code
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
Address
Tel
Email

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
2018 Year 08 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
2018 Year 06 Month 20 Day
Last modified on
2018 Year 06 Month 20 Day


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

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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