UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012708
Receipt number R000014840
Scientific Title the induction of the inhalation theraphy of hypoxic gas for the congenital heart disease patients with increased pulmonary flow
Date of disclosure of the study information 2013/12/26
Last modified on 2013/12/26 19:33:07

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Basic information

Public title

the induction of the inhalation theraphy of hypoxic gas for the congenital heart disease patients with increased pulmonary flow

Acronym

hypoxic gas inhalation theraphy for the congenital heart disease

Scientific Title

the induction of the inhalation theraphy of hypoxic gas for the congenital heart disease patients with increased pulmonary flow

Scientific Title:Acronym

hypoxic gas inhalation theraphy for the congenital heart disease

Region

Japan


Condition

Condition

congenital heart disease with increased pulmonary blood flow

Classification by specialty

Pediatrics Cardiovascular surgery Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

perioperative control of respiratory and cardiac failure for the congenital heart disease patients with increased pulmonary blood flow

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

adverse events

Key secondary outcomes

clinical efficacy of the therapy during perioperative period


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

Medicine

Interventions/Control_1

inhalation of hypoxic gas for the congenital heart disease patients with increased pulmonary blood flow

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


Not applicable

Age-upper limit

1 years-old >

Gender

Male and Female

Key inclusion criteria

the congenital heart disease patients with increased pulmonary blood flow who cannot be controlled adequate pulmonary blood flow by conventional thrapy

Key exclusion criteria

none

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Tamai

Organization

Osaka Medical College

Division name

Deparment of Pediatrics

Zip code


Address

2-7, Daigaku-machi, Takatsuki, Osaka

TEL

072-683-1221

Email

ped001@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Katayama

Organization

Osaka Medical College

Division name

Deparment of Pediatrics

Zip code


Address

2-7, Daigaku-machi, Takatsuki, Osaka

TEL

072-683-1221

Homepage URL


Email

ped100@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

none

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

大阪医科大学付属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 26 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

the therapy was performed for 5 patients
(HLHS; 3 patients, CoA complex and 18 trisomy; 1, PA with IVS; 1)
age at the induction: 3-14 days
body weight at the induction: 1264-2981g
duration of the therapy: 2days; 2patients, 3days; 2, 28days; 1)
reason for the termination of the therapy
surgery(bilateral PA banding) 3, improvement of lung congestion; 1, transfer to the other hospital; 1
no adverse events

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

2010 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 25 Day

Last follow-up date

2013 Year 11 Month 30 Day

Date of closure to data entry

2013 Year 11 Month 30 Day

Date trial data considered complete

2013 Year 11 Month 30 Day

Date analysis concluded

2014 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 26 Day

Last modified on

2013 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name