UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033064 |
|---|---|
| Receipt number | 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 | 2021/12/24 15:05:18 |
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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 | 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
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
s-matsumoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037696
