UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010916 |
|---|---|
| Receipt number | R000012775 |
| Scientific Title | Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2016/06/10 20:54:33 |
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Basic information
Public title
Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management
Acronym
Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management
Scientific Title
Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management
Scientific Title:Acronym
Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management
Region
| Japan |
Condition
Condition
All Congenital Heart Desease
Classification by specialty
| Pediatrics | Cardiovascular surgery | Operative medicine |
| Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficasy of the industrial Nitric oxide and Nitrogen gas inhalation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient hemodynamics in perioperative period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Inhalation of the industrial Nitric oxide and Nitrogen gas
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 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Pulmonary hypertension by echocardiography
Key exclusion criteria
Patients without Pulmonary hypertension by echocardiography or those who has no congenital heart defect
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Fujimoto |
Organization
Shimane University
Division name
Cardiovascular Surgery
Zip code
Address
89-1, Ennya, Izumo City, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
yoshi-sleepingcat@crest.ocn.ne.jp
Sponsor or person
Institute
Department of Cardiovascular
And Chest Surgery, Shimane University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2013 | Year | 06 | Month | 10 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012775
