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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026382
Receipt No. R000030315
Scientific Title Pharmacokinetics/Pharmacodynamics of Nitroglycerin in pediatric pulmonary hypertension with congenital heart disease
Date of disclosure of the study information 2017/03/15
Last modified on 2017/03/03

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Basic information
Public title Pharmacokinetics/Pharmacodynamics of Nitroglycerin in pediatric pulmonary hypertension with congenital heart disease
Acronym PK/PD of NTG in pediatric pulmonary hypertension
Scientific Title Pharmacokinetics/Pharmacodynamics of Nitroglycerin in pediatric pulmonary hypertension with congenital heart disease
Scientific Title:Acronym PK/PD of NTG in pediatric pulmonary hypertension
Region
Japan

Condition
Condition Pediatric congenital heart disease
Classification by specialty
Pediatrics Intensive care medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify an optimal dosage and therapeutic window of NTG in pediatric pulmonary hypertension
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Therapeutic window of NTG
Key secondary outcomes Relationship between efficiency and adverse effect, and NTG concentration in blood

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuous intravenous infusion of NTG starts at 2 microg/kg/min when cardiopulmonary bypass is weaned. In PICU, dose of NTG will increase by 1 or 2 microg/kg/min depending on a pulmonary arterial pressure. The interval time of dosage change requires at least 20 minutes. Maximum dosage of NTG is set to be 10 microg/kg/min.
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
6 years-old >=
Gender Male and Female
Key inclusion criteria Children who will undergo an operation with pulmonary hypertension in congenital heart disease
Key exclusion criteria 1) Palliated operation and single ventricle cases
2) Who are regarded as unsuitable by a doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Nagano
Organization Jichi Children's Medical Center Tochigi, Jichi Medical University
Division name Department of Pediatric intensive care and Anesthesia
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7716
Email tnagano@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Nagano
Organization Jichi Children's Medical Center Tochigi, Jichi Medical University
Division name Department of Pediatric intensive care and Anesthesia
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7716
Homepage URL
Email tnagano@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
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 自治医科大学(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 15 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
2017 Year 03 Month 03 Day
Last modified on
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030315

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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