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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014987
Receipt No. 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

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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
Email 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
Email imai-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017301

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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