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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025139
Receipt No. R000028910
Scientific Title Remifentanil prevents increases of blood glucose and lactate during cardiopulmonary bypass in pediatric cardiac surgery
Date of disclosure of the study information 2016/12/05
Last modified on 2016/12/04

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Basic information
Public title Remifentanil prevents increases of blood glucose and lactate during cardiopulmonary bypass in pediatric cardiac surgery
Acronym Remifentanil prevents blood glucose and lactate elevations during pediatric CPB
Scientific Title Remifentanil prevents increases of blood glucose and lactate during cardiopulmonary bypass in pediatric cardiac surgery
Scientific Title:Acronym Remifentanil prevents blood glucose and lactate elevations during pediatric CPB
Region
Japan

Condition
Condition Congenital heart disease
Classification by specialty
Vascular surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the preventive effect of remifentanil on the elevation of blood glucose and lactate levels during cardiopulmonary bypass in pediatric congenital heart disease surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose and lactate levels just before and after cardiopulmonary bypass
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
0 years-old <=
Age-upper limit
7 years-old >=
Gender Male and Female
Key inclusion criteria children received atrial or ventricular septal defect repair under cardiopulmonary bypass
Key exclusion criteria children with glucose tolerance abnormality or hyperlactatemia
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Chaki
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email chakitomohiro0728@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Chaki
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email chakitomohiro0728@yahoo.co.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University School of Medicine
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
2016 Year 12 Month 05 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 analyzing

Management information
Registered date
2016 Year 12 Month 04 Day
Last modified on
2016 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028910

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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