UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012438 |
|---|---|
| Receipt number | R000014337 |
| Scientific Title | The changes of plasma and alveolar inflammatory mediators levels during cardiac surgery under cardiopulmonary bypass |
| Date of disclosure of the study information | 2013/11/29 |
| Last modified on | 2013/11/29 00:25:24 |
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Basic information
Public title
The changes of plasma and alveolar inflammatory mediators levels during cardiac surgery under cardiopulmonary bypass
Acronym
The changes of plasma and alveolar inflammatory mediators levels during cardiac surgery under cardiopulmonary bypass
Scientific Title
The changes of plasma and alveolar inflammatory mediators levels during cardiac surgery under cardiopulmonary bypass
Scientific Title:Acronym
The changes of plasma and alveolar inflammatory mediators levels during cardiac surgery under cardiopulmonary bypass
Region
| Japan |
Condition
Condition
cardiac surgery patients
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether dexmedetomidine or remifentanil infusion during surgery attenuates the systemic inflammatory response after cardiac surgery using cardiopulmonary bypass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma and alveolar inflammatory mediators (HMGB1 and IL-6) level, liver function, renal function, myocardial function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
remifentanil administration 0.25 microg/kg/hr i.v. intraoperatively
Interventions/Control_2
dexmedetomidine administration 0.5 microg/kg/hr i.v. intraoperatively
Interventions/Control_3
control group (received the same volume of saline)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years of age or older who underwent elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria
previous heart surgery, infection disease, chronic administration of an anti-inflammatory treatment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kawasaki |
Organization
University of Occupational and Environmental Health
Division name
Department of Anesthesiology
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 JAPAN
TEL
093-691-7265
takasi-k@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kawasaki |
Organization
University of Occupational and Environmental Health
Division name
Department of Anesthesiology
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 JAPAN
TEL
093-691-7265
Homepage URL
takasi-k@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
産業医科大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 29 | 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
| 2012 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 07 | 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
| 2013 | Year | 11 | Month | 29 | Day |
Last modified on
| 2013 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014337
