UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Industrial Nitric oxide and Nitrogen gas inhalation for patients with congenital heart disease during the perioperative management
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshifumi Fujimoto
Organization	Shimane University
Division name	Cardiovascular Surgery
Address	89-1, Ennya, Izumo City, Shimane
TEL
Email

Public contact
Name of contact person
Organization	Shimane University
Division name	Cardiovascular Surgery
Address
TEL
Homepage URL
Email	yoshi-sleepingcat@crest.ocn.ne.jp

Sponsor
Institute	Department of Cardiovascular And Chest Surgery, Shimane University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012775