UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014987 |
|---|---|
| Receipt number | R000017301 |
| Scientific Title | A randomized exploratory trial for evaluating cardioprotective and anti-inflammatory activities of remifentanil preconditioning in patients undergoing off-pump coronary artery bypass graft surgery |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2017/04/08 23:26:07 |
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Basic information
Public title
A randomized exploratory trial for evaluating cardioprotective and anti-inflammatory activities of remifentanil preconditioning in patients undergoing off-pump coronary artery bypass graft surgery
Acronym
Cardioprotective and anti-inflammatory activities of remifentanil preconditioning in patients undergoing OPCAB
Scientific Title
A randomized exploratory trial for evaluating cardioprotective and anti-inflammatory activities of remifentanil preconditioning in patients undergoing off-pump coronary artery bypass graft surgery
Scientific Title:Acronym
Cardioprotective and anti-inflammatory activities of remifentanil preconditioning in patients undergoing OPCAB
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate influences of remifentanil preconditioning on myocardial injury, inflammatory responses, and postoperative complications in patients undergoing OPCAB, by comparing with the placebo treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in cardiac troponin I levels between before the first anastomosis and 12h after the last one
Key secondary outcomes
1. Changes in cardiac markers (cTnI, CK-MB, and h-FABP)
2. Intraoperative complications
3. Postoperative complications
4. Postoperative recovery
5. Changes in HMGB-1
6. Changes in inflammatory and anti-inflammatory cytokines (IL-6, IL-8, TNF-alpha, GM-CSF, and IL-10)
7. Changes in peripheral blood leukocyte mRNA expression
8. Changes in total and differential leukocyte count
9. Changes in stress hormones (cortisol and ACTH)
10. Changes in CRP
11. Perioperative vital signs
12. Perioperative cardiac function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil group:
to receive remifentanil infusion at a rate of 0.5mcg/kg/min (0.3ml/kg/h) for 30 minutes between induction of general anesthesia and sternotomy.
Interventions/Control_2
Placebo group:
to receive 0.9% saline infusion at a rate of 0.3ml/kg/h for 30 minutes between induction of general anesthesia and sternotomy.
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
1. Patients with acute coronary syndrome scheduled for elective OPCAB with multiple distal anastomoses (>= 3) via a median sternotomy approach
2. 20 years or older at the time of obtaining informed consent
3. Patients with written informed consent
Key exclusion criteria
1. Patients with unstable angina
2. Patients with history of acute myocardial infarction within 4 weeks prior to surgery
3. Patients with low cardiac output (EF < 30%, inotropic or mechanical circulatory support before surgery)
4. Patients who had prior CABG
5. Patients who had percutaneous coronary intervention within 6 weeks prior to surgery
6. Patients scheduled for combined surgery involving a second organ
7. Patients with opioid use
8. Patients with corticosteroid use
9. Patients with insulin or sulfonylurea use
10. Patients with an active concomitant infection
11. Patients with chronic inflammation (autoimmune disease or malignancy)
12. Patients who have received remifentanil within 3 months prior to surgery
13. Patients with BMI >= 30
14. Patients with atrial fibrillation, second- or third- degree atrioventricular block, or left bundle branch block
15. Patients with moderate or severe aortic or mitral valve disease
16. Patients with severe renal disease (eGFR < 30ml/min/1.73m2)
17. Patients with severe hepatic dysfunction (AST or ALT >= 100IU/l)
18. Patients with severe pulmonary disease (intestinal pneumonia, COPD, or asthma treated with medication)
19. Female patients who are pregnant or possibly pregnant
20. Female patients who are breastfeeding
21. Patients who have received any investigational drug within 3 months before initiation of this trial
22. Patients whom principal investigator or co-investigator judges to be inappropriate as a participant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Yamada |
Organization
The University of Tokyo Hospital
Division name
The Anesthesiology and Pain Relief Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-3815-5411
yamaday-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yousuke Imai |
Organization
The University of Tokyo Hospital
Division name
The Anesthesiology and Pain Relief Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
03-3815-5411
Homepage URL
imai-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | 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
| 2014 | Year | 08 | Month | 29 | Day |
Last modified on
| 2017 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017301
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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