UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026382 |
|---|---|
| Receipt number | 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 13:52:34 |
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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
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
tnagano@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030315
