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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012242
Receipt No. R000014313
Scientific Title Effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery
Date of disclosure of the study information 2013/11/08
Last modified on 2016/11/09

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Basic information
Public title Effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery
Acronym Effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery
Scientific Title Effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery
Scientific Title:Acronym Effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery
Region
Japan

Condition
Condition Children under 36 months who is scheduled for surgical closure of atrial septum defect or ventricular septum defect
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of propofol administration on pancreatic enzymes and lipid biochemistry in children undergoing open heart surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum triglycerides, serum cholesterol, serum phospholipids, serum high-density lipoproteins, serum low-density lipoproteins, serum very low-density lipoproteins, serum total lipids, serum amylase, serum lipase
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 1% propofol
Interventions/Control_2 2% propofol
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
1 months-old <=
Age-upper limit
36 months-old >
Gender Male and Female
Key inclusion criteria Patient with atrial septal defect or ventricular septal defect who is scheduled for surgical closure of the defect.
Key exclusion criteria hepatic, renal, neurological or respiratory disease, fat intolerance or any congenital metabolic disorder
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichiro Mizuno
Organization Fukuoka Children's Hospital
Division name Department of Anesthesia
Zip code
Address 5-1-1 Kashii-Teriha, Higashi-ku, Fukuoka, 813-0017, Fukuoka, Japan
TEL 092-682-7000
Email mizuno.k@fcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Mizuno
Organization Fukuoka Children's Hospital
Division name Department of Anesthesia
Zip code
Address 5-1-1 Kashii-Teriha, Higashi-ku, Fukuoka, 813-0017, Fukuoka, Japan
TEL 092-682-7000
Homepage URL
Email mizuno.k@fcho.jp

Sponsor
Institute Fukuoka Children's Hospital
Institute
Department

Funding Source
Organization Fukuoka Children's Hospital Pediatric Research Foundation
Organization
Division
Category of Funding Organization Local Government
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
2013 Year 11 Month 08 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
2013 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 11 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 08 Day
Last modified on
2016 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014313

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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